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Targeted Drug Delivery Systems

Targeted Drug Delivery Systems
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Study Participants

Centers

The following tables and graphs were generated based on data collected between August 7, 2003 and the report cut-off date of July 31, 2016. Sixty centers enrolled and contributed patients to the targeted drug delivery systems section of the report.


Patients

As the table below demonstrates, there were 7,459 total targeted drug delivery system patients enrolled through July 31, 2016. As indicated, 58.1% of patients were implanted with a targeted drug delivery system for treatment of non malignant pain (pain not related to cancer and its treatment), followed by 21.6% for treatment of spasticity, and 18.5% for treatment of malignant pain (pain related to cancer). Primary treatment indication is provided by the physician.

Targeted Drug Delivery System Primary Treatment IndicationsTargeted Drug Delivery System Primary Treatment Indications

Targeted Drug Delivery System Primary Treatment Indications


Targeted Drug Delivery System Primary Treatment Indications
Primary Treatment Indicationa Total Enrolled Patients (Percent)
Pain 5,709 (76.5%)
Non-Malignant Pain 4.332 (58.1%)
Malignant Pain 1,377 (18.5%)
Spasticity 1,611 (21.6%)
Combination 87 (1.2%)
Non-Malignant Pain & Spasticity 87 (1.2%)
Not Specified 52 (0.7%)
Total Subjects 7,459

a Refer to product labeling for approved indications.

Malignant Pain Sub-Indications Total Enrolled Patients (Percent)a
Location of Pain
Spine/Back 441 (32.0%)
Abdominal/Visceral 296 (21.5%)
Extremity 189 (13.7%)
Pelvic 183 (13.3%)
Thoracic 156 (11.3%)
Head/Neck 80 (5.8%)
Other 76 (5.5%)
Not Specified 441 (32.0%)
Total Patients 1,377

a Percent is based on the number of total patients.

Non-Malignant Pain Sub-Indications Total Enrolled Patients (Percent)
Back Pain without Leg Pain 1,376 (31.1%)
Back Pain with Leg Pain 1,225 (27.7%)
General Neuropathic Condition 176 (4.0%)
CRPS Ia 136 (3.1%)
Peripheral Neuropathy 74 (1.7%)
Joint Pain/Arthritis 63 (1.4%)
CRPS IIa 34 (0.8%)
General Nociceptive Condition 32 (0.7%)
Osteoporosis 20 (0.5%)
Other 322 (7.3%)
Not Specified 961 (21.7%)
Total Patientsb 4,419

a CRPS is complex regional pain syndrome. CRPS I rarely includes detectable peripheral nerve injury. CRPS II includes detectable peripheral nerve or plexus injury.
b Includes patients with indications of non-malignant pain and a combination of non-malignant pain and spasticity.

Spasticity Sub-Indications Total Enrolled Patients (Percent)
Cerebral Palsy 450 (26.5%)
Multiple Sclerosis 446 (26.3%)
Spinal Cord Injury 241 (14.2%)
Brain Injury 125 (7.4%)
Stroke 68 (4.0%)
Other 94 (5.5%)
Not Specified 274 (16.1%)
Total Patientsa 1,698

a Includes patients with indications of spasticity and a combination of non-malignant pain and spasticity.

Event Summary

There were 4,934 events reported between August 2003 and July 31, 2016 in patients with targeted drug delivery systems. Approximately 28% of these events (1,393/4,934) were categorized as product performance-related events and are presented graphically within this report. The 1,393 product performance events occurred in 982 of the 7,459 total patients (13.17%) enrolled. In addition, there were 3,541 non-product performance events reported. There were also 1,784 deaths reported for patients with targeted drug delivery systems. None of these deaths were reported as a direct result of a product performance event. Early versions of the protocol required events to be reported only when the event required a surgical intervention, resulted in therapy abandonment, or resulted in death. The required event reporting definition was expanded in April 2010 to include all adverse events related to the device, implant procedure, and/or therapy. The event tables provided below include combined data from these versions of the protocol.

Targeted Drug Delivery System Product Performance Events
Eventa Number of Product Performance Events Number of Patients with Eventb Percent of Patients with Event (n=7,459)

Catheter occlusionc

280 257 3.45%

Catheter dislodgement

273 236 3.16%

Catheter break/cut

188 169 2.27%

Pump motor stall

132 112 1.50%

Catheter kink

124 113 1.51%

Catheter related complicationd

56 52 0.70%

Device malfunctione

44 41 0.55%

Catheter disconnection at pump

41 41 0.55%

Catheter leakage

39 38 0.51%

Pump reservoir volume discrepancy

33 28 0.38%

Corrosion and/or gear wear

28 28 0.38%

Pump unable to enter/withdraw from catheter access port

22 19 0.25%

Pump underinfusion

20 17 0.23%

Overinfusionf

18 12 0.16%

Pump connector break/cut

17 16 0.21%

Medical device complicationg

12 10 0.13%

Reduced battery performance

9 9 0.12%

Deformed pump tube

7 6 0.08%

Device breakage

5 5 0.07%

Catheter access port issue

4 4 0.05%

Device use error

4 4 0.05%

Catheter disconnection between catheter segments

3 3 0.04%

Device alarm issue

3 3 0.04%

Motor feedthrough anomaly

3 3 0.04%

Pump not infusing

3 3 0.04%

Reservoir access issues due to residue

3 2 0.03%

Catheter damage

2 2 0.03%

Device connection issue

2 2 0.03%

Device difficult to use

2 2 0.03%

Device issue

2 2 0.03%

Alarm and/or resonator anomaly

1 1 0.01%

Coil shorted to case

1 1 0.01%

Concave pump shield

1 1 0.01%

Connector block problem

1 1 0.01%

Cracked rotor magnet holder

1 1 0.01%

Device component issueh

1 1 0.01%

Device deployment issue

1 1 0.01%

Device infusion issuej

1 1 0.01%

Device telemetry issue

1 1 0.01%

Gear or bridging residue

1 1 0.01%

Leaky capacitor

1 1 0.01%

Product sedimentation present

1 1 0.01%

Pump inversion

1 1 0.01%

Not Codedj

1 1 0.01%
Totals 1,393 982 13.17%

a Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term or Medtronic’s coding system term for events that do not exist in the MedDRA dictionary.
b The total number of patients with events may not represent the sum of all rows, as a patient may have experienced more than one type of event.
c Includes events reported as catheter occlusion and catheter kink/occlusion.
d Includes 18 catheter malfunctions, 15 inability to aspirate from catheter, 4 suspected catheter malfunctions, 4 coiled catheters, 2 difficulty aspirating catheter, 2 non-functioning distal catheter, 1 inability to aspirate CSF, 1 poor CSF flow, 1 aneurysm in catheter, 1 catheter wrapped in coils and knots, 1 catheter wrapped around pump, 1 evidence of catheter wear, 1 catheter failure, 1 no free flow of CSF from spinal segment of catheter, 1 patency issues of catheter, 1 slight loop in catheter, and 1 catheter occlusion.
e Includes 25 PTM malfunctions, 8 suspected catheter malfunctions, 6 pump malfunctions, 1 clinician programmer malfunction, 1 catheter dysfunction, 1 possible pump malfunction, 1 suspected rotor problem, and 1 catheter anchor malfunction.
f There were a total of 24 pumps with overinfusion (physician reported or confirmed by returned product analysis). The events for 15 of these pumps are reported in the table above. The remaining 9 pumps had no reported events associated with explant but had returned product analysis confirmed overinfusion (not reflected in the table above but included in the occurrence rate of overinfusion indicated in the Pump Events section of this report). The 15 pumps represented in the above table had 21 events; 18 events for overinfusion, and 3 events for pump motor stall.
g Includes 1 pump connector appeared somewhat worn, 1 pump unable to interrogate, 1 sutureless connector failure, 1 roller arm seized to ball bearing, 1 pump beeped, 1 pump in safe state, 1 possible corrosion of pump due to concentration of drug, 1 possible corrosion of catheter due to concentration of drug, 1 worn catheter connector, 1 metal clips on sutureless connector bent, 1 prescription table corruption, and 1 pump absorption of drug.
h Includes 1 event reported as broken anchor.
i Includes 1 event reported as slow dosing at refills.
j Event that had not been MedDRA-coded at the time of the report cut-off.

A total of 1,054 (75.7%) of the 1,393 product performance events were related to the catheter, 274 (19.7%) were related to the pump, 38 (2.7%) were reported as related to an external device, 17 (1.2%) were related to “multiple etiologies,” which includes events where at least one device and one non-device etiology was indicated, 3 (0.2%) were related to surgery/anesthesia, 2 (0.1%) were related to incisional site/device tract, 2 (0.1%) were related to MRI, 1 (0.1%) was related to programming/refill, 1 (0.1%) was related to medication, and 1 (0.1%) was related to some “other” etiology. Relatedness is determined by the physician.

Product Performance Events by Relatednessa

 

Product Performance Events by Relatedness
                 a Each event could have more than one etiology.

 

 
Targeted Drug Delivery System Non-Product Performance Events (including adverse eventsa and device events, excluding deaths and normal battery depletions)
Eventb Number of Non-Product Performance Events
Therapeutic and nontherapeutic effects (excluding toxicity) 998
     Adverse drug reaction 725
     Drug withdrawal syndrome 121
     Therapeutic product ineffective 99
     Therapeutic response decreased 40
     No therapeutic response 10
     Otherc 3
Administration site reactions 622
     Implant site pain 251
     Implant site extravasation 157
     Implant site erosion 34
     Implant site erythema 29
     Catheter site pain 22
     Inflammatory mass (Possible) 18
     Catheter site fibrosis 17
     Implant site haematoma 16
     Implant site swelling 14
     Inflammatory mass (Confirmed) 13
     Implant site inflammation 6
     Otherc 45
Infections - pathogen unspecified 322
     Inplant site infection 218
     Wound infection 35
     Meningitis 22
     Infection 18
     Incision site infection 14
     Otherc 15
Device issues 317
     Pump inversion 158
     Pump migration 74
     Device difficult to use 26
     Device malfunction 19
     Pump reservoir volume discrepancy 6
     Device use error 5
     Catheter break/cut 5
     Pump unable to enter/withdraw from catheter access port 5
     Otherc 19
Complications associated with device 226
     Pump motor stalld 186
     Medical device discomfort 27
     Medical device complicatione 5
     Drug-related pump anomaly 5
     Otherc 3
General system disorders Not Elsewhere Classified (NEC) 214
     Pain 132
     No anomaly found by RPAf 40
     Oedema peripheral 18
     Asthenia 5
     Otherc 19
Neurological disorders (NEC) 212
     Cerebrospinal fluid leakage 102
     Hypoaesthesia 43
     Sedation 16
     Somnolence 15
     Paraesthesia 10
     Hyperaesthesia 8
     Otherc 18
Procedural related injuries and complications NEC 195
     Wound dehiscence 67
     Seroma 35
     Post lumbar puncture syndrome 27
     Procedural complication 8
     Anaesthetic complication 5
     Otherc 53
Medication errors 44
     Overdose 41
     Otherc 3
Muscle disorders 38
     Muscular weakness 30
     Muscle spasms 8
Headaches 37
     Headache 37
Urinary tract signs and symptoms 34
     Urinary retention 25
     Dysuria 7
     Otherc 2
Neuromuscular disorders 31
     Muscle spasticity 27
     Otherc 4
Epidermal and dermal conditions 26
     Erythema 9
     Pruritus 6
     Otherc 11
Gastrointestinal signs and symptoms 22
     Nausea 11
     Vomiting 7
     Other c 4
Musculoskeletal and connective tissue disorders NEC 21
     Back pain 12
     Otherc 9
Exposures, chemical injuries and poisoning 19
     Toxicity to various agents 19
Psychiatric disorders NEC 18
     Mental status changes 15
     Otherc 3
Bacterial infectious disorders 16
     Inmplant site cellulitis 7
     Cellulitis 5
     Otherc 4
Tissue disorders NEC 16
     Impaired healing 15
     Otherc 1
Vascular haemorrhagic disorders 9
     Haematoma 9
Therapeutic procedures and supportive care NEC 8
     Incisional drainage 5
     Otherc 3
Gastrointestinal motility and defaecation conditions 6
    Constipation 6
Mental impairment disorders 6
     Memory impairment 5
     Otherc 1
Skin and subcutaneous tissue disorders NEC 6
     Skin erosion 6
Otherc 78
Total 3,541

a Adverse events associated with product performance events are not included in this table.
b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms or Medtronic's own coding system terms for events that do not exist in the MedDRA dictionary.
c Composed of event codes with fewer than 5 events each.
d 186 pump motor stalls occurred due to MRI and recovered in less than 24 hours with no pump issues.
e Includes events reported as 1 pump poorly positioned,1 difficulty locating pump port due to patient weight gain, 1 possible catheter sheath, 1 inadvertent overfilling of the pump at refill, and 1 mis-filling of pump into pocket.
f For products that are returned with a suspected device issue, and RPA establishes a root cause or finds no anomaly, results reported herein reflect the finding from Returned Product Analysis (RPA).

 

There were 1,784 deaths reported for patients with targeted drug delivery systems. None of the deaths were reported as a direct result of a product performance event. One death was reported by the physician as possibly related to the intrathecal medications in a patient who expired due to pulmonary embolism. A second death was reported by the physician as due to acute respiratory failure following a device procedure, and was reported as possibly related to the device and implant procedure. A total of 1,086 (60.9%) of deaths occurred in patients receiving therapy for malignant pain, 528 (29.6%) for non-malignant pain, 164 (9.2%) for spasticity, 4 (0.2%) for non-malignant pain and spasticity, and 2 (0.1%) for patients whose primary indication was not specified.

Deaths by Primary Indication
Primary Indicationa N (%)
Malignant pain 1,086 (60.9%)
Non-malignant pain 528 (29.6%)
Spasticity 164 (9.2%)
Non-Malignant Pain & Spasticity 4 (0.02%)
Not specified 2 (0.1%)
Total 1,784

a Refer to product labeling for approved indications.

Pumps

From August 2003 to the report cut-off date of July 31, 2016, there were 9,014 pumps followed in the registry. The difference between the total number of patients (n=7,459) versus pumps is due to the fact that some patients were subsequently re-implanted with a pump multiple times. The aggregate prospective follow-up time for all pumps was 237,699 months (19,808 years). The table below provides the number and percentage of pumps by model.

Pumps by Model
Model Name Number of Pumps (%)
SynchroMed II 7,825 (86.8%)
Unspecified 2 (<0.1%)
Pumps No Longer Manufactured
SynchroMed EL 1,182 (13.1%)
SynchroMed 5 (<0.1%)
Total 9,014 (100%)

 

Pump EventsPump Events

There were 279 product performance-related events with an underlying reported etiology related to pump function.

  • 274 events had a pump etiology, and 5 events had both a pump and other etiology (including device and non-device).
    • 138 pumps were analyzed by Medtronic Returned Product Analysis (RPA) with the following analysis findings: 66 motor stalls, 28 corrosion and/or gear wear, 17 overinfusion, 9 reduced battery performance, 6 deformed pump tube, 3 motor feedthrough anomaly, 2 reservoir access issue due to residue, 1 alarm and/or resonator anomaly, 1 coil shorted to case, 1 concave pump shield, 1 cracked rotor magnet holder, 1 leaky capacitor, 1 gear or bridging residue, and 1 medical device complication. Of these 138 pumps with RPA-confirmed malfunction events, 26 were originally reported as non-product performance-related battery depletions by the physician.
      • The current return rate of pumps to Medtronic RPA was 1067/3,980 (26.8%). The proportion was based upon the number of registry pumps received by RPA, divided by the total number of explanted pumps plus the total number of pumps in patients who expired.
    • 141 events were characterized based upon physician report only (pumps were not returned to Medtronic) and included: 63 events due to physician-reported motor stalls, 28 pump reservoir discrepancies, 17 pump underinfusion, 9 device malfunctions, 6 medical device complications, 5 pump unable to enter/withdraw from catheter access port, 3 pump not infusing, 3 device alarm issues, 2 catheter occlusions, 2 pump connector break/cut, 1 catheter break/cut, 1 device telemetry issue, and 1 overinfusion.
  • 224 were the initial product performance event that affected pump survival estimates.

In addition to the 279 product performance-related events, there were 12 pump events reported as normal battery depletion by the physician, which were returned to Medtronic and had a RPA observation of high battery resistance. For this analysis, these pumps were categorized as having non-product performance-related battery depletion events, because they represented normal implant duration (ranging from 5.6-6.8 years) with no associated physician or patient complaint.

Medtronic executed a field action in March 2014 informing healthcare professionals of overinfusion associated with the SynchroMed II Infusion System. In September 2016, an updated customer letter was provided which stated an overinfusion occurrence rate for registry patients. This rate was based on pumps which had both laboratory overinfusion through returned product analysis and an in-vivo complaint of either clinical overinfusion symptoms or lower than expected residual volume. This definition was used because environmental factors during shipping may impact the results of returned product testing. There were 5 pumps in the registry that met this definition as stated in the customer letter. The 5 pumps with overinfusion provided 95% confidence that the occurrence rate is less than 0.0014 (0.14%).

The laboratory overinfusion rate for all registry pumps with overinfusion found through returned product analysis was also assessed. As of July 31, 2016, this included the 5 pumps described above in the customer letter, and 18 additional pumps for a total of 23 pumps from registry patients with laboratory overinfusion. Of these 23 pumps with laboratory overinfusion, 14 had an event reported in the registry, and the remaining 9 had no reported events associated with the pump. The 23 findings of laboratory overinfusion occurred in 7,825 SynchroMed II pumps included in the registry at the time of analysis, providing 95% confidence that the occurrence rate is less than 0.0042 (0.42%).

In addition to the 23 pumps with laboratory overinfusion after returned product analysis, there was 1 pump with physician reported overinfusion that was not returned for analysis. Combining the physician reported and laboratory overinfusion (n=24) provided 95% confidence that the total occurrence rate is less than 0.0043 (0.43%). Medtronic continues to monitor pump performance relative to overinfusion.

Overinfusion Rate

  In Vivo & Laboratory Overinfusiona Laboratory Overinfusionb Laboratory or Physician Reportedc Overinfusion

Number of Pumps

5 23 24

Occurrence Rated

0.14% 0.42% 0.43%

a
From September 2016 Field Action letter. Rate based on total of 7,505 pumps (January 31, 2016 data cut-off).
b Laboratory overinfusion by Returned Product Analysis. Rate based on a total of 7,825 pumps (July 31, 2016 data cut-off).
c There was one pump with physician reported overinfusion which was not returned for analysis. Rate based on a total of 7,825 pumps (July 31, 2016 data cut-off).
d Upper one-sided exact 95% confidence interval.

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For pumps:

  • 224 were cut-off due to product performance-related events.
  • 6,412 were censored in the survival analysis for the following reasons: patient expired, pump explanted, site termination, patient discontinued, patient lost to follow-up, other pump modification, therapy suspended, or non-product performance pump-related event with no associated intervention.
  • 2,378 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Pump SurvivalPump Survival

The figures and tables below represent pump survival and 95% confidence intervals where at least 20 pumps contributed to each 3-month interval. Medtronic chose to voluntarily discontinue the SynchroMed EL pump in August 2007 in the United States.

                                                                                    
   

Model 8627-18 SynchroMed EL 18mL: Survival from Pump Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8627-18 SynchroMed EL 18mL: Survival from Pump Events

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Pump Characteristics
Model Name SynchroMed II (18 mL)
FDA Approval Date Mar 1999
Pumps Enrolled 1,148
Pumps Currently Active in Study 1
Device Events 34
Cumulative Months of Follow-up 31,052

 

Summary Table
Pump Event Total
Corrosion and/or gear wear 17
Pump underinfusion 6
Pump motor stall 5
Medical device complicationa 2
Cracked rotor magnet holder 1
Gear or bridging residue 1
Motor feedthrough anomaly 1
Reduced battery performance 1
Total Pump Events 34

a Includes 1 event for unable to interrogate/program pump and 1 roller arm seized to ball bearing.

Time Interval Survival
(95% Confidence Intervals)
Sample Size
1 yr 98.8%
(95.3%, 99.7%)
181
2 yrs 97.4%
(94.2%, 98.9%)
374
3 yrs 95.8%
(92.6%, 97.6%)
535
4 yrs 94.9%
(91.8%, 96.9%)
590
5 yrs 93.7%
(90.5%, 95.8%)
468
6 yrs 92.3%
(88.9%, 94.7%)
245
7 yrs 91.3%
(87.6%, 94.0%)
108
8 yrs 90.4%
(86.1%, 93.4%)
36
at 99 mo 90.4%
(86.1%, 93.4%)
23

Model 8627-18 SynchroMed EL 18mL: Specifications

Expected battery lifea 3-7 years ppr-8627-18
Thickness 1.08 in (27.5 mm)
Diameter (with integral access port) 3.35 in (85.2 mm)
Capacity 18.0 mL
Minimal Programmable Flow Rateb 0.048 mL/day
Maximum Programmable Flow Rateb 21.6 mL/day

a Dependent on flow rate
b Actual limits depend on pump calibration constant and selected infusion mode.

Model 8637-20 SynchroMed II 20mL: Survival from Pump Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8637-20 SynchroMed II 20mL: Survival from Pump Events

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Pump Characteristics
Model Name SynchroMed II (20 mL)
FDA Approval Date Sep 2003
Pumps Enrolled 3,049
Pumps Currently Active in Study 1,167
Device Events 62
Cumulative Months of Follow-up 94,287

 

SynchroMed II 20mL Event Summary Table
Pump Event Total
Pump motor stall 25
Pump reservoir volume discrepancy 8
Corrosion and/or gear wear 4
Device malfunctiona 4
Overinfusion 3
Pump unable to enter/withdraw from catheter access port 3
Medical device complication b 2
Motor feedthrough anomaly 2
Reduced battery performance 2
Alarm and/or resonator anomaly 1
Catheter occlusion 1
Deformed pump tube 1
Device alarm issue 1
Device telemetry issue 1
Pump connector break/cut 1
Pump not infusing 1
Pump underinfusion 1
Reservoir access issues due to residue 1
Total Pump Events 62

a Includes 3 events for pump malfunction and 1 event for suspected rotor problem.
bIncludes 1 event for pump beeped and 1 event for pump in safe state.

Time Interval Survival
(95% Confidence Intervals)
Sample Size
1 yr 99.8%
(99.5%, 99.9%)
2,027
2 yrs 99.4%
(99.0%, 99.7%)
1,623
3 yrs 98.7%
(98.1%, 99.2%)
1,196
4 yrs 97.9%
(97.0%, 98.6%)
869
5 yrs 96.6%
(95.2%, 97.5%)
612
6 yrs 93.9%
(91.8%, 95.4%)
391
at 81 mo 89.2%
(84.3%, 92.6%)
43

Model 8637-20 SynchroMed II 20mL: Specifications

Expected battery lifea 6-7 years ppr-8637-20
Thickness 0.77 in (19.5 mm)
Diameter 3.4 in (87.5 mm)
Capacity 20.0 mL
Minimal Programmable Flow Rateb 0.048 mL/day
Maximum Programmable Flow Rateb 24 mL/day
Minimum Rate Infusion Modec 0.006 mL/day

a Dependent on flow rate
b Actual limits depend on pump calibration constant and selected infusion mode.
c Nontherapeutic (if therapy is to be temporarily discontinued)

Model 8637-40 SynchroMed II 40mL: Survival from Pump Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8637-40 SynchroMed II 40mL: Survival from Pump Events

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Pump Characteristics
Model Name SynchroMed II (40 mL)
FDA Approval Date Sep 2003
Pumps Enrolled 4,776
Pumps Currently Active in Study 1,393
Device Events 127
Cumulative Months of Follow-up 111,401

 

SynchroMed II 40mL Event Summary Table
Pump Event Total
Pump motor stall 67
Pump reservoir volume discrepancy 11
Pump underinfusion 8
Overinfusion 8
Corrosion and/or gear wear 6
Reduced battery performance 5
Deformed pump tube 4
Device malfunction a 4
Device alarm issue 2
Medical device complication b 2
Pump not infusing 2
Pump unable to enter/withdraw from catheter access port 2
Catheter occlusion c 1
Coil shorted to case 1
Concave pump shield 1
Leaky capacitor 1
Pump connector break/cut 1
Reservoir access issues due to residue 1
Total Pump Events 127

a Includes 2 events for pump malfunction, 1 event for suspected pump malfunction, and 1 event for suspected catheter dysfunction attributed to both pump and catheter.
b Includes 1 event for under medicated event that was attributed to the pump and 1 possible corrosion of pump due to concentration of drug.
c Includes 1 event for catheter occlusion that was attributed to the pump and catheter.

Time Interval Survival
(95% Confidence Intervals)
Sample Size
1 yr 99.2%
(98.9%, 99.5%)
2,564
2 yrs 98.7%
(98.2%, 99.1%)
1,857
3 yrs 97.7%
(96.9%, 98.2%)
1,313
4 yrs 95.9%
(94.7%, 96.8%)
902
5 yrs 92.2%
(90.4%, 93.7%)
591
6 yrs 88.4%
(85.9%, 90.5%)
351
at 81 mo 83.7%
(77.4%, 88.4%)
37

Model 8637-40 SynchroMed II 40mL: Specifications

Expected battery lifea 6-7 years ppr-8637-40
Thickness 1.0 in (26 mm)
Diameter 3.4 in (87.5 mm)
Capacity 40.0 mL
Minimal Programmable Flow Rateb 0.048 mL/day
Maximum Programmable Flow Rateb 24 mL/day
Minimum Rate Infusion Modec 0.006 mL/day

a Dependent on flow rate
b Actual limits depend on pump calibration constant and selected infusion mode.
c Nontherapeutic (if therapy is to be temporarily discontinued)

Pump Survival SummaryPump Survival Summary

Pump Characteristics
Model Name Family FDA Approval
Date
Pumps
Enrolled
Pumps
Currently
Active
in Study
Device
Eventsa
Cumulative Months of
Follow-up
SynchroMed EL (18 mL) SynchroMed EL Mar 1999 1,148 1 34 31,052
SynchroMed II (20 mL) SynchroMed II Sep 2003 3,049 1,167 62 94,287
SynchroMed II (40 mL) SynchroMed II Sep 2003 4,776 1,393 127 111,401

a There were a total of 279 pump-related events reported to the registry, but only 223 events included in this summary table. The remaining events either occurred in pump models for which no device survival curves are presented due to an insufficient number of enrolled devices (i.e., SynchroMed EL 10 mL[n=1]) or were subsequent events (ie additional events that occurred after the survival censoring event) that did not affect the device survival estimates.

Device Survival Probability (95% Confidence Intervals)Table 1 of 2
Model Name 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 7 yrs 8 yrs
SynchroMed EL (18 mL) 98.8%
(95.3%, 99.7%)
97.4%
(94.2%, 98.9%)
95.8%
(92.6%, 97.6%)
94.9%
(91.8%, 96.9%)
93.7%
(90.5%, 95.8%)
92.3%
(88.9%, 94.7%)
91.3%
(87.6%, 94.0%)
90.4%
(86.1%, 93.4%)
SynchroMed II (20 mL) 99.8%
(99.5%, 99.9%)
99.4%
(99.0%, 99.7%)
98.7%
(98.1%, 99.2%)
97.9%
(97.0%, 98.6%)
96.6%
(95.2%, 97.5%)
93.9%
(91.8%, 95.4%)
- -
SynchroMed II (40 mL) 99.2%
(98.9%, 99.5%)
98.7%
(98.2%, 99.1%)
97.7%
(96.9%, 98.2%)
95.9%
(94.7%, 96.8%)
92.2%
(90.4%, 93.7%)
88.4%
(85.9%, 90.5%)
- -
Device Survival Probability (95% Confidence Intervals)Table 2 of 2
Model Name 5 yrs 6 yrs 7 yrs 8 yrs
SynchroMed EL (18 mL) 93.7%
(90.5%, 95.8%)
92.3%
(88.9%, 94.7%)
91.3%
(87.6%, 94.0%)
91.3%
(87.6%, 94.0%)
SynchroMed II (20 mL) 96.6%
(95.2%, 97.6%)
94.7%
(92.7%, 96.2%)
- -
SynchroMed II (40 mL) 93.4%
(91.5%, 94.9%)
90.0%
(87.4%, 92.10%)
- -

Product Performance of SynchroMed II Pumps Exposed to On-Label and Off-Label Medications Product Performance of SynchroMed II Pumps Exposed to On-Label and Off-Label Medications

The purpose of this section of the report is to provide additional information regarding the product performance of SynchroMed II pumps exposed to On-Label and Off-Label medications. This section contains information outside the FDA approved labeling for Medtronic's SynchroMed II Infusion System. It is recognized that healthcare providers prescribe therapies to meet specific patient needs; however, Medtronic only directs the use of its products according to FDA approved labeling. Medtronic does not market its products for Off-Label indications and makes no representations regarding the efficacy for Off-Label uses. Infumorph®, Prialt®, Lioresal® and Gablofen® are the only intrathecal FDA approved formulations for the Medtronic SynchroMed II Infusion System. The long term drug stability/compatibility and safety and/or efficacy of drugs not FDA approved for use with the SynchroMed II Infusion System has not been established.

Patient status updates were obtained every 6 months or until discontinuation of therapy or the patient was lost to follow-up. Medications within the pump were recorded at each 6-month follow-up. This provided a snapshot of medication use at these points in time. The registry did not capture every medication or medication concentration used in the pump since any medication or concentration changes that occurred between follow-up visits were not recorded.

Pump Groups – On/Off Label Categorization

There were 6,666 patients enrolled in the registry that had SynchroMed II pumps implanted. Of these patients, 56% were female and 44% were male with a mean age of 54.0 (SD = 17.3). Of the 7,825 SynchroMed II pumps enrolled through July 31, 2016, at least one drug record was available for 7,519 pumps. If a pump had no drug records, the pump was not classified, and was excluded from analyses comparing On-Label to Off-Label. Pumps were categorized as being On7ndash; or Off-Label using the following criteria:

  • On-Label: If a pump has at least one drug record in the registry, and none of the records show Off-Label drug exposure, that pump is considered On-Label even if the complete drug history of that pump is unknown.
    • For pumps used for pain patients, if the drug record has only one drug and it is morphine sulfate or ziconotide these pumps are considered On-Label.
    • o For pumps used for spasticity patients, if the drug record has only one drug, and it is baclofen, Lioresal® or Gablofen®, that drug record is considered On-Label. Note: The classification was based on the name of the drug only, not the reported concentration of the drug.
    • Pumps with an On-Label drug history and currently containing preservative free water or preservative free saline, or if previously contained preservative free water/saline and currently containing on-label drug were considered On-Label.
  • Off-Label: Any drugs not specified above within the approved indications are considered Off-Label. Additionally, any drug record with more than one drug at a time in the pump (admixture) is considered Off-Label.
    • If a pump had any known exposure to Off-Label drugs (i.e., the Off-Label data have been collected in the registry), that pump is considered Off-Label, regardless of the amount of exposure time.
    • If a pump is filled with a medication that was reported as compounded, that pump is considered Off-Label.

Data Analysis

Survival estimates were calculated using the methods described in the Methodology section of this report. Statistical testing that compared survival curves was performed using a Cox proportional-hazards model. Since the survival estimate may become very imprecise with small sample sizes, Medtronic Neuromodulation’s registry truncates device survival curves when the sample size is less than 20 active devices. At this threshold, one device failure yields a 5% decrease in cumulative survival. Additionally, the standard error for this survival estimate is approximately 5% (depending on previous conditional survival estimates), with 95% confidence intervals of approximately ± 10%. Overall, this large variability of 20% around the cumulative survival estimate would greatly reduce the precision for the point estimate.

Pump survival from product performance-related events was calculated and compared for the following groups:

  • All pumps: On-Label vs. Off-Label Drugs (including all indications)
  • Pain: On-Label vs. Off-Label Drugs (including all pain)
  • Spasticity: On-Label vs. Off-Label Drugs (including all spasticity)

Additionally, the cumulative failure rate (i.e. the estimated probability that a pump will have a product performance-related event by a given time point) is presented in table and graph formats for each of the sub-groups listed above.

Results

                                                                                    
   

Total Study Population: A total of 2,330 SynchroMed II pumps were classified as On-Label where there was no evidence of Off-Label drug/admixture exposure. A total of 5,189 pumps were classified as Off-Label where there was evidence of pump exposure to an Off-Label drug/admixture.

Demographic table


Indication a: N (Row %)
On-Label
N=2,330
Off-Label
N=5,189

Non-Malignant Pain

748 (16.9%) 3,685 (83.1%)

Malignant Pain

38 (3.0%) 1,225 (97.0%)

Spasticity

1,544 (89.2%) 187 (10.8%)

Multiple/Unknown

NA 92

a Refer to product labeling for approved indications.

There were a total of 189 reported SynchroMed II pump failures (i.e. had product performance event) during the study observation period. In addition to the 189 pump failures, there were 12 pump events reported as normal battery depletion, but had a Returned Product Analysis (RPA) observation of high battery resistance. For this analysis, these pumps were not considered failures because they represented normal implant duration ranging from 5.6 – 6.8 years with no associated physician or patient complaint. Three of the 189 pump failure events occurred in pumps with no drug records available. Of the remaining 186 SynchroMed II pump failures, 92 were classified as pump failure due to motor stall (with or without documented motor corrosion). The remaining pump failures were due to events such as corrosion and/or gear wear, inconsistent pump reservoir volume, pump under infusion, and other non-conforming reasons. Overall, the rate of pump failures in this cohort was 2.5% (186/7,519) with a median follow-up of 19.8 months.

For the 92 pump failures due to motor stall, 44 of the events were associated with the patient presenting clinical signs and symptoms of possible drug withdrawal or increasing pain or spasticity. The other 48 events had no patient reported signs and symptoms associated with the event, but had a physician report of a motor stall occurrence. There were no issues reported when pumps were replaced and/or re-started, such as drug overdose. None of the pump failures resulted in patient death.

The table below presents SynchroMed II pump survival for the entire population and is stratified by the On-Label or Off-Label pump group.

Total study population: Survival from product performance-related pump events for all indications, by On/Off-Label drug exposure for SynchroMed II pumps

Category Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 81 mo 7 yrs 87 mo
All Pumps Survival 99.5% 99.0% 98.1% 96.8% 94.3% 91.1% 86.3% 85.1% 85.1%
Number
of
pumps
4,511 3,433 2,482 1,747 1,192 740 80 30 21
On-Label Drugs Survival 99.7% 99.5% 98.8% 98.1% 96.3% 94.5% 92.6% - -
Number
of
pumps
1,481 1,131 811 563 398 233 20 - a - a
Off-Label Drugs Survival 99.4% 98.8% 97.8% 96.2% 93.4% 89.5% 84.0% 82.4% -
Number
of
pumps
3,030 2,302 1,671 1,184 794 507 60 21 - a

a Sample size is less than 20 active devices at 7 years for On-Label pump group, and at 87 months for both On and Off-Label pump groups.

The cumulative survival curve of the SynchroMed II pump for the entire population, and stratified by the On-Label or Off-Label pump group, is shown below.

SynchroMed II cumulative survival (All therapies)

Data are shown if there are at least 20 devices in each 3-month interval.

SynchroMed II cumulative survival (All therapies)

View Larger Image

The table and figure below present the complementary cumulative failure rate estimates (Failure=100%-Survival), with the scale of the figure expanded to more clearly show the differences between the groups. The table and graph depict the cumulative failure rate over time and estimate the risk of pump failure for specific implant durations (i.e. time period from pump implant). Overall, the pumps with known Off-Label drug exposure had a 1.9 times greater risk of failure than pumps with no known Off-Label drug exposure (p=0.0004).

Total study population: Cumulative failure of SynchroMed II pumps due to product performance-related pump events for all indications, by On/Off-Label drug exposure

Category Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 81 mo 7 yrs 87 mo
All Pumps Failure 0.5% 1.0% 1.9% 3.2% 5.7% 8.9% 13.7% 14.9% 14.9%
Number
of
pumps
4,511 3,433 2,482 1,747 1,192 740 80 30 21
On-Label Drugs Failure 0.3% 0.5% 1.2% 1.9% 3.7% 5.5% 7.4% - -
Number
of
pumps
1,481 1,131 811 563 398 233 20 -a -a
Off-Label Drugs Failure 0.6% 1.2% 2.2% 3.8% 6.6% 10.5% 16.0% 17.6% -
Number
of
pumps
3,030 2,302 1,671 1,184 794 507 60 21 -a

a Sample size is less than 20 active devices at 7 years for On-Label pump group, and at 87 months for both On and Off-Label pump groups.

SynchroMed II cumulative failure (All therapies)

Data are shown if there are at least 20 devices in each 3-month interval.

SynchroMed II cumulative failure (All therapies)

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Overall Summary and Limitations

  • Pump failures have been observed in pumps with both On-Label and Off-Label medications used for all indications over the follow-up period.
  • Off-Label medication exposure is associated with an overall 1.9 times greater risk of pump failure compared to On-Label medication exposure for the entire pump population. The rate of pump failure accelerates in the Off-Label group after 36 months of follow-up. At 81 months of follow-up, the survival from pump failure for On-Label pumps was 92.6%, compared to a survival of 84.0% for Off-Label pumps.
  • The data represent the reported registry experience with a median follow-up time of 19.8 months. The longer term data are based on a lower number of pumps and are subject to change as more follow-up data are obtained via the registry. Survival curve truncation or plateaus do not imply that the implanted devices will not be adversely impacted beyond the time points of the current data.
  • The On-Label pump group was comprised of 66% spasticity as the indication (1,544 vs. 786: Spasticity versus Pain pumps respectively). On the other hand, the Off-Label group consisted of 95% pain indications (4,910 vs. 187: Pain versus Spasticity pumps respectively).
  • Medication use was recorded as a snapshot at the time of follow-up. It is possible that some On-Label pumps received Off-Label medications in between 6-month follow-up periods. In addition, it is possible that some pumps designated as On-Label received compounded formulation of an On-Label equivalent (i.e. Lioresal) but was not designated as such in the registry database.
  • The time a pump was exposed to an Off-Label medication was not assessed. It is possible that some Off-Label pumps were exposed only for a brief time period (e.g. < 6 months).
  • The risk of pump failure by type of drug was not assessed. Many Off-Label pumps were exposed to multiple medications over the life span of the pump. This limits the ability to associate a specific drug, compounded drug, drug concentration, or drug combination with increased pump failure risk.

Pain Study Population: A total of 786 SynchroMed II pumps were classified as On-Label for pain therapy, where there was no evidence of Off-Label drug/admixture exposure. A total of 4,910 pumps were classified as Off-Label where there was evidence of pump exposure to an Off-Label pain drug/admixture.

The table below presents SynchroMed II pump survival for the Pain indications and is stratified by the On-Label or Off-Label pump group.

Pain study population: Survival from product performance-related pump events for Pain indications, by On/Off-Label drug exposure for SynchroMed II pumps

Categorya Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 81 mo
Pain Overall Survival 99.4% 98.8% 97.8% 96.2% 93.4% 89.6% 88.8% 83.7%
Number
of
pumps
3,290 2,446 1,748 1,202 805 514 414 59
Pain On-Label Survival 99.6% 98.9% 97.2% 97.2% 95.7% 95.7% 95.7% -
Number
of
pumps
444 285 178 97 61 37 31 - b
Pain Off-Label Survival 99.4% 98.8% 97.9% 96.1% 93.2% 89.1% 88.2% 83.2%
Number
of
pumps
2,846 2,161 1,570 1,105 744 477 383 54

a Refer to product labeling for approved Pain indications.
b Sample size is less than 20 active devices at 81 months for Pain On-Label pump group

The cumulative survival of the SynchroMed II pump for the Pain indications, and stratified by the On-Label or Off-Label pump group, is shown below.

SynchroMed II cumulative survival (Pain)

Data are shown if there are at least 20 devices in each 3-month interval.

SynchroMed II cumulative survival (Pain)

View Larger Image

The table and figure below present the complementary cumulative failure rate estimates (Failure=100%-Survival), with the scale of the figure expanded to more clearly show the differences between the groups. The difference in survival between the On-Label and Off-Label groups for the pumps in the pain population was similar to what was observed for the entire population (all therapies). There was no statistically significant difference in the risk of failure between the On-Label and Off-Label pumps implanted for the treatment of pain (p=0.31); however, the limited number of On-Label pumps may be insufficient to detect a difference.

Pain study population: Cumulative failure of SynchroMed II pumps due to product performance-related pump events for Pain indications, by On/Off-Label drug exposure

Categorya Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 81 mo
Pain Overall Failure 0.6% 1.2% 2.2% 3.8% 6.6% 10.4% 11.2% 16.3%
Number
of
pumps
3,290 2,446 1,748 1,202 805 514 414 59
Pain On-Label Failure 0.4% 1.1% 2.8% 2.8% 4.3% 4.3% 4.3% -
Number
of
pumps
444 285 178 97 61 37 31 - b
Pain Off-Label Failure 0.6% 1.2% 2.1% 3.9% 6.8% 10.9% 11.8% 16.8%
Number
of
pumps
2,846 2,161 1,570 1,105 744 477 383 54

a Refer to product labeling for approved Pain indications.
b Sample size is less than 20 active devices at 81 months for Pain On-Label pump group.

SynchroMed II cumulative failure (Pain)

Data are shown if there are at least 20 devices in each 3-month interval.

SynchroMed II cumulative failure (All therapies)

View Larger Image

Overall Summary and Limitations

  • Pump failures have been observed in pumps with both On-Label and Off-Label medications used for all indications over the follow-up period.
  • Off-Label medication exposure is associated with an overall 1.9 times greater risk of pump failure compared to On-Label medication exposure for the entire pump population. The rate of pump failure accelerates in the Off-Label group after 36 months of follow-up. At 81 months of follow-up, the survival from pump failure for On-Label pumps was 92.6%, compared to a survival of 84.0% for Off-Label pumps.
  • The data represent the reported registry experience with a median follow-up time of 19.8 months. The longer term data are based on a lower number of pumps and are subject to change as more follow-up data are obtained via the registry. Survival curve truncation or plateaus do not imply that the implanted devices will not be adversely impacted beyond the time points of the current data.
  • The On-Label pump group was comprised of 66% spasticity as the indication (1,544 vs. 786: Spasticity versus Pain pumps respectively). On the other hand, the Off-Label group consisted of 95% pain indications (4,910 vs. 187: Pain versus Spasticity pumps respectively).
  • Medication use was recorded as a snapshot at the time of follow-up. It is possible that some On-Label pumps received Off-Label medications in between 6-month follow-up periods. In addition, it is possible that some pumps designated as On-Label received compounded formulation of an On-Label equivalent (i.e. Lioresal) but was not designated as such in the registry database.
  • The time a pump was exposed to an Off-Label medication was not assessed. It is possible that some Off-Label pumps were exposed only for a brief time period (e.g. < 6 months).
  • The risk of pump failure by type of drug was not assessed. Many Off-Label pumps were exposed to multiple medications over the life span of the pump. This limits the ability to associate a specific drug, compounded drug, drug concentration, or drug combination with increased pump failure risk.

Spasticity Study Population: A total of 1,544 SynchroMed II pumps were classified as On-Label for spasticity therapy, where there was no evidence of Off-Label drug/admixture exposure. A total of 187 pumps were classified as Off-Label where there was evidence of pump exposure to an Off-Label spasticity drug/admixture.

The table below presents SynchroMed II pump survival for the Spasticity indication and is stratified by the On-Label or Off-Label pump group.

Spasticity study population: Survival from product performance-related pump events for Spasticity indication, by On/Off-Label drug exposure for SynchroMed II pumps

Categorya Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 78 mo 81 mo
Spasticity Overall Survival 99.7% 99.7% 99.2% 98.5% 96.6% 94.8% 94.3% 94.3% 94.3%
Number
of
pumps
1,176 960 720 537 386 226 141 59 21
Spasticity On-Label Survival 99.7% 99.7% 99.3% 98.5% 96.6% 94.6% 94.0% 94.0% -
Number
of
pumps
1,037 846 633 466 337 196 118 46 -b
Spasticity Off-Label Survival 100.0% 99.2% 98.1% 98.1% 96.4% 96.4% 96.4% - -
Number
of
pumps
139 114 87 71 49 30 23 -b -b

a Refer to product labeling for approved Spasticity indication.
b Sample size is less than 20 active devices at 78 months for Spasticity Off-Label pump group, and at 81 months for both on-label and off-label pump groups.

The cumulative survival curve of the SynchroMed II pump for the Spasticity indication, and stratified by the On-Label or Off-Label pump group, is shown below.

SynchroMed II cumulative survival (Spasticity)

Data are shown if there are at least 20 devices in each 3-month interval.

SynchroMed II cumulative survival (Spasticity)

View Larger Image

The table and figure below present the complementary cumulative failure rate estimates (Failure=100%-Survival), with the scale of the figure expanded to more clearly show the differences between the groups. Overall the survival for the On-Label pumps was similar to the entire pump population (all therapies). There was no statistically significant difference in the risk of failure between the On-Label and Off-Label pumps implanted for the treatment of Spasticity (p=0.75); however, the limited number of Off-Label pumps may be insufficient to detect a difference.

Spasticity study population: Cumulative failure of SynchroMed II pumps due to product performance-related pump events for Spasticity indication, by On/Off-Label drug exposure

Categorya Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 78 mo 81 mo
Spasticity Overall Failure 0.3% 0.3% 0.8% 1.5% 3.4% 5.2% 5.7% 5.7% 5.7%
Number
of
pumps
1,176 960 720 537 386 226 141 59 21
Spasticity On-Label Failure 0.3% 0.3% 0.7% 1.5% 3.4% 5.4% 6.0% 6.0% -
Number
of
pumps
1,037 846 633 466 337 196 118 46 -b
Spasticity Off-Label Failure 0.0% 0.8% 1.9% 1.9% 3.6% 3.6% 3.6% - -
Number
of
pumps
139 114 87 71 49 30 23 -b -b

a Refer to product labeling for approved Spasticity indication
b Sample size is less than 20 active devices at 78 months for Spasticity Off-Label pump group, and at 81 months for Spasticity On-Label and Off-Label groups.

SynchroMed II cumulative failure (Spasticity)

Data are shown if there are at least 20 devices in each 3-month interval.

SynchroMed II cumulative failure (Spasticity)

View Larger Image

Overall Summary and Limitations

  • Pump failures have been observed in pumps with both On-Label and Off-Label medications used for all indications over the follow-up period.
  • Off-Label medication exposure is associated with an overall 1.9 times greater risk of pump failure compared to On-Label medication exposure for the entire pump population. The rate of pump failure accelerates in the Off-Label group after 36 months of follow-up. At 81 months of follow-up, the survival from pump failure for On-Label pumps was 92.6%, compared to a survival of 84.0% for Off-Label pumps.
  • The data represent the reported registry experience with a median follow-up time of 19.8 months. The longer term data are based on a lower number of pumps and are subject to change as more follow-up data are obtained via the registry. Survival curve truncation or plateaus do not imply that the implanted devices will not be adversely impacted beyond the time points of the current data.
  • The On-Label pump group was comprised of 66% spasticity as the indication (1,544 vs. 786: Spasticity versus Pain pumps respectively). On the other hand, the Off-Label group consisted of 95% pain indications (4,910 vs. 187: Pain versus Spasticity pumps respectively).
  • Medication use was recorded as a snapshot at the time of follow-up. It is possible that some On-Label pumps received Off-Label medications in between 6-month follow-up periods. In addition, it is possible that some pumps designated as On-Label received compounded formulation of an On-Label equivalent (i.e. Lioresal) but was not designated as such in the registry database.
  • The time a pump was exposed to an Off-Label medication was not assessed. It is possible that some Off-Label pumps were exposed only for a brief time period (e.g. < 6 months).
  • The risk of pump failure by type of drug was not assessed. Many Off-Label pumps were exposed to multiple medications over the life span of the pump. This limits the ability to associate a specific drug, compounded drug, drug concentration, or drug combination with increased pump failure risk.

Catheters

From August 2003 to the report cut-off date of July 31, 2016, there were 8,463 catheters followed in the registry. The total number of catheters was not equal to the total number of pumps (n=9,014) because patients may have undergone pump replacements but used the same catheters, or patients may have been implanted with Medtronic pumps and non-Medtronic catheters which were not registered with Medtronic Device and Registrant Tracking system (DART). The aggregate prospective follow-up time for all catheters was 236,702 months (19,725 years). The table below provides the number and percentage of catheters by model.

Catheters by Model
Model Number of Catheters (%)
8709 (InDura) 2,833 (33.5%)
8709SC (InDura 1P) 1,036 (12.2%)
8780 (Ascenda) 701 (8.3%)
8711 (InDura) 652 (7.7%)
8781 (Ascenda) 607 (7.2%)
8731SC (w/ sutureless connector) 222 (2.6%)
Revised Not As Designeda 645 (7.6%)
Grafted Not As Designedb 445 (5.3%)
Other 252 (3.0%)
Revised As Designedc 217 (2.6%)
Ascenda RADd 166 (2.0%)
Catheters No Longer Manufactured
8731 503 (5.9%)
8703W 184 (2.2%)
Total 8,463 (100%)

a Medtronic non-8731 catheters that had been repaired with an 8596 proximal or 8598 distal revision kit.
b Catheters that involve the ad-hoc assembly of components other than a Medtronic repair kit or brand new catheter.
c 8731 catheters that had been repaired with an 8596 proximal or 8598 distal revision kit.
d 8780 or 8781 catheters repaired with the 8782 or 8784 revision kit.

Catheter EventsCatheter Events

There were 1,064 product performance events reported to the registry that were related to the catheter. This includes 1,054 events with a catheter etiology, and 10 events with both a catheter and other etiology (including device and non-device etiologies). The majority of the events were catheter occlusion (n=276), catheter dislodgement (n=241), break or cut in the catheter (n=186), or catheter kink (124). Of the 1,064 events, 925 were the initial product performance event that affected catheter survival estimates.

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For catheters:

  • 925 had follow-up time cut-off due to product performance-related events.
  • 5,142 were censored in the survival analysis for the following reasons: patient expired, catheter explanted/capped, site termination, patient discontinued, patient lost to follow-up, other catheter modification, therapy suspended, or non-product performance catheter-related event without an associated intervention.
  • 2,396 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Catheter SurvivalCatheter Survival

The figures and tables below represent catheter survival and 95% confidence intervals where at least 20 catheters contributed to each 3-month interval. Survival curves are only shown if more than 20 devices had at least 12 months of follow-up at the time of the report cut-off for each model.

Medtronic catheter repair kits and 2-piece catheters include specially designed connector pins and strain relief sleeves to splice the catheter segments together. Catheters grafted not as designed, by definition, involve the ad-hoc assembly of components other than those from a Medtronic repair kit or brand new catheter. Medtronic recommends that clinicians follow the labeling for the catheter revision kits.

                                                               
   

Model 8709: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8709: Survival from Catheter Events

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Catheter Characteristics
Model Number 8709
FDA Approval Date May 1998
Catheters Enrolled 2,833
Catheters Currently Active in Study 288
Device Events 309
Cumulative Months of Follow-up 81,797
Model 8709: Event Summary Table
Catheter Event Total
Catheter dislodgement 85
Catheter occlusion 72
Catheter break/cut 70
Catheter kink 22
Catheter disconnection at pump 18
Catheter leakage 10
Catheter related complicationa 10
Pump connector break/cut 9
Device malfunction 2
Medical device complicationb 2
Pump unable to enter/withdraw from catheter access port 2
Pump underinfusion 2
Catheter disconnection between catheter segments 1
Deformed pump tube 1
Device infusion issuec 1
Motor stall 1
Reservoir access issues due to residue 1
Total Catheter Events 309

a Includes 3 events reported as unable to aspirate catheter, 2 catheter malfunctions, 1 coiled catheter, 1 aneurysm in catheter,1 possible catheter malfunction, 1 unable to aspirate CSF, and 1 difficulty aspirating catheter.
b Includes 1 event for pump connector appeared somewhat worn, and 1 for possible catheter corrosion due to concentration of drug.
c Reported as slow dosing at refills.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.1%
(90.4%, 93.5%)
963
2 yrs 89.4%
(87.4%, 91.1%)
908
3 yrs 86.1%
(83.9%, 88.0%)
847
4 yrs 83.2%
(80.8%, 85.3%)
752
5 yrs 80.6%
(78.0%, 82.9%)
626
6 yrs 76.0%
(73.1%, 78.6%)
533
7 yrs 71.3%
(68.2%, 74.2%)
440
8 yrs 68.9%
(65.6%, 72.0%)
350
9 yrs 67.4%
(63.9%, 70.6%)
259
10 yrs 65.2%
(61.5%, 68.7%)
192
11 yrs 62.7%
(58.6%, 66.5%)
135
12 yrs 60.1%
(55.5%, 64.3%)
95
13 yrs 57.7%
(52.5%, 62.5%)
64
14 yrs 57.7%
(52.5%, 62.5%)
40
15 yrs 55.7%
(49.4%, 61.6%)
26

 

Model 8709: Specifications

Total Length 89 cm Model 8709
Outer diameter (spinal segment) 1.4 mm (4.2 French)
Inner Diameter (spinal segment) 0.53 mm
Catheter Tip Description Closed with 6 side holes
Catheter Volume 0.0022 mL/cm
Trimmable Segments Pump end

Model 8709SC: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8709sc: Survival from Catheter Events

View Larger Image

Catheter Characteristics
Model Number 8709SC
FDA Approval Date Mar 2006
Catheters Enrolled 1,036
Catheters Currently Active in Study 291
Device Events 115
Cumulative Months of Follow-up 32,258
Model 8709SC: Event Summary Table
Catheter Event Total
Catheter dislodgement 32
Catheter break/cut 27
Catheter occlusion 24
Catheter related complicationa 8
Catheter kink 6
Catheter leakage 6
Catheter disconnection at pump 3
Pump unable to enter/withdraw from catheter access port 2
Catheter damage 1
Catheter disconnection between catheter segments 1
Device connection issue 1
Device malfunction 1
Medical device complicationb 1
Product sedimentation present 1
Pump inversion 1
Total Catheter Events 115

a Includes 3 events reported as catheter malfunction, 1 coiled catheter, 1 catheter occlusion, 1 catheter unable to aspirate, 1 catheter wrapped around pump, and 1 slight loop in catheter.
b Reported as sutureless connector failure.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 93.9%
(92.0%, 95.4%)
659
2 yrs 89.4%
(86.9%, 91.5%)
511
3 yrs 87.1%
(84.3%, 89.4%)
419
4 yrs 83.9%
(80.7%, 86.7%)
299
5 yrs 82.2%
(78.6%, 85.2%)
186
6 yrs 81.1%
(77.2%, 84.4%)
112
7 yrs 76.4%
(71.0%, 81.0%)
67
8 yrs 76.4%
(71.0%, 81.0%)
23
at 99 mo 76.4%
(71.0%, 81.0%)
20

 

Model 8709SC: Specifications

Total Length 89 cm Model 8709SC
Outer diameter (spinal segment) 1.4 mm (4.2 French)
Inner Diameter (spinal segment) 0.53 mm
Catheter Tip Description Closed tip, radiopaque, titanium with 6 side holes
Catheter Volume 0.0022 mL/cm
Trimmable Segments Pump end

Model 8711: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8711: Survival from Catheter Events

View Larger Image

Catheter Characteristics
Model Number 8711
FDA Approval Date Oct 1999
Catheters Enrolled 652
Catheters Currently Active in Study 156
Device Events 86
Cumulative Months of Follow-up 23,973
Model 8711: Event Summary Table
Catheter Event Total
Catheter occlusion 27
Catheter break/cut 18
Catheter dislodgement 14
Catheter related complicationa 13
Catheter kink 5
Pump unable to enter/withdraw from catheter access port 3
Catheter disconnection at pump 2
Catheter access port issue 1
Catheter leakage 1
Device malfunction 1
Pump connector break/cut 1
Total Catheter Events 86

a Includes 6 events reported as catheter malfunction, 3 unable to aspirate catheter, 2 non-functioning spinal catheters, 1 no free flow of CSF from spinal segment of catheter, and 1 difficulty aspirating catheter.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.5%
(88.9%, 94.9%)
309
2 yrs 90.0%
(86.1%, 92.9%)
286
3 yrs 84.9%
(80.4%, 88.4%)
252
4 yrs 82.7%
(78.0%, 86.5%)
219
5 yrs 81.6%
(76.7%, 85.5%)
195
6 yrs 77.7%
(72.3%, 82.2%)
154
7 yrs 74.1%
(68.3%, 79.1%)
135
8 yrs 71.7%
(65.5%, 76.9%)
89
9 yrs 69.8%
(63.2%, 75.5%)
57
10 yrs 65.9%
(58.1%, 72.5%)
45
11 yrs 62.6%
(53.9%, 70.2%)
31
12 yrs 60.6%
(51.1%, 68.7%)
29
13 yrs 57.9%
(47.3%, 67.0%)
21

 

Model 8711: Specifications

Total Length 104.1 cm Model 8711
Outer diameter (spinal segment) 1.4 mm (4.2 French)
Inner Diameter (spinal segment) 0.53 mm
Catheter Tip Description Closed with 6 side holes
Catheter Volume 0.0022 mL/cm
Trimmable Segments Spinal and pump ends

Model 8731: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8731: Survival from Catheter Events

View Larger Image

Catheter Characteristics
Model Number 8731
FDA Approval Date Oct 2002
Catheters Enrolled 503
Catheters Currently Active in Study 71
Device Events 50
Cumulative Months of Follow-up 20,109
Model 8731: Event Summary Table
Catheter Event Total
Catheter occlusion 19
Catheter dislodgement 19
Catheter kink 3
Catheter related complicationa 3
Catheter break/cut 2
Catheter disconnection at pump 2
Device malfunction 1
Pump connector break/cut 1
Total Catheter Events 50

a Includes 1 event reported as patency issue with catheter, 1 coiled catheter, and 1 catheter malfunction.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 93.6%
(88.8%, 96.3%)
260
2 yrs 92.3%
(87.5%, 95.3%)
302
3 yrs 91.3%
(86.5%, 94.4%)
251
4 yrs 89.3%
(84.3%, 92.8%)
193
5 yrs 87.7%
(82.4%, 91.5%)
145
6 yrs 82.3%
(76.1%, 87.0%)
129
7 yrs 78.7%
(71.9%, 84.0%)
93
8 yrs 76.0%
(68.6%, 81.8%)
71
9 yrs 74.8%
(67.2%, 80.9%)
61
10 yrs 74.8%
(67.2%, 80.9%)
48
11 yrs 72.8%
(64.2%, 79.7%)
35
at 138 mo 72.8%
(64.2%, 79.7%)
22

 

Model 8731: Specifications

Total Length 104.1 cm Model 8731
Outer diameter (spinal segment) 1.4 mm (4.2 French)
Inner Diameter (spinal segment) 0.53 mm
Catheter Tip Description Closed tip, radiopaque, with 6 side holes
Catheter Volume 2.22mL/cm
Trimmable Segments Spinal end

Model 8731SC: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8731sc: Survival from Catheter Events

View Larger Image

Catheter Characteristics
Model Number 8731SC
FDA Approval Date Mar 2006
Catheters Enrolled 222
Catheters Currently Active in Study 110
Device Events 16
Cumulative Months of Follow-up 5,786
Model 8731SC: Event Summary Table
Catheter Event Total
Catheter occlusion 8
Catheter dislodgment 5
Catheter disconnection at pump 1
Catheter leakage 1
Pump unable to enter/withdraw from catheter access port 1
Total Catheter Events 16
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 94.8%
(89.9%, 97.4%)
122
2 yrs 91.3%
(85.0%, 95.0%)
87
3 yrs 90.0%
(83.0%, 94.2%)
64
4 yrs 88.3%
(80.4%, 93.2%)
42
5 yrs 86.2%
(76.9%, 91.9%)
32
6 yrs 86.2%
(76.9%, 91.9%)
21
at 81 mo 82.2%
(68.9%, 90.2%)
23

 

Model 8731SC: Specifications

Total Length 104.1 cm Model 8731SC
Outer diameter (spinal segment) 1.4 mm (4.2 French)
Inner Diameter (spinal segment) 0.53 mm
Catheter Tip Description Closed with 6 side holes
Catheter Volume 0.0022 mL/cm
Trimmable Segments Spinal and pump end

Model 8780: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8731sc: Survival from Catheter Events

View Larger Image

Catheter Characteristics
Model Number 8780
FDA Approval Date Sept 2012
Catheters Enrolled 701
Catheters Currently Active in Study 500
Device Events 44
Cumulative Months of Follow-up 9,810
Model 8780: Event Summary Table
Catheter Event Total
Catheter occlusion 19
Catheter dislodgement 9
Catheter kink 8
Catheter break/cut 3
Catheter disconnection at pump 2
Catheter leakage 2
Catheter related complicationa 1
Total Catheter Events 44

a Reported as unable to aspirate catheter.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 93.4%
(90.8%, 95.3%)
348
2 yrs 90.5%
(87.1%, 93.0%)
172
3 yrs 89.6%
(85.7%, 92.5%)
34
at 39 mo 89.6%
(85.7%, 92.5%)
22

 

Model 8780: Specifications

Total Length 114 cm Model 8780
Outer diameter (spinal segment) 1.2 mm (4.0 French)
Inner Diameter (spinal segment) 0.5 mm
Catheter Tip Description Closed with 6 side holes
Catheter Volume 0.0022 mL/cm
Trimmable Segments Connector end of the spinal segment

Model 8781: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Model 8731: Survival from Catheter Events

View Larger Image

Catheter Characteristics
Model Number 8781
FDA Approval Date Sept 2012
Catheters Enrolled 607
Catheters Currently Active in Study 346
Device Events 50
Cumulative Months of Follow-up 5,479
Model 8781: Event Summary Table
Catheter Event Total
Catheter kink 21
Catheter dislodgement 14
Catheter occlusion 7
Catheter disconnection at pump 2
Catheter break/cut 1
Catheter leakage  1
Catheter related complicationa 1
Device issue 1
Pump reservoir volume discrepancy 1
Pump underinfusion 1
Total Catheter Events 50

a Reported as possible catheter malfunction.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 87.6%
(83.4%, 90.8%)
169
2 yrs 85.5%
(80.5%, 89.3%)
60
at 33 mo 82.5%
(75.8%, 87.5%)
28

 

Model 8781: Specifications

Total Length 140 cm PPR Model 8781
Outer diameter (spinal segment) 1.2 mm (4.0 French)
Inner Diameter (spinal segment) 0.5 mm
Catheter Tip Description Closed with 6 side holes
Catheter Volume 0.0022 mL/cm
Trimmable Segments Catheter connector ends of the spinal and pump segments

Revised As Designed Catheters: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Revised As Designed Catheters: Survival from Catheter Events

View Larger Image


Catheter Characteristics
Model Name Revised As Designed
FDA Approval Date Oct 2002
Catheters Enrolled 217
Catheters Currently Active in Study 75
Device Events 33
Cumulative Months of Follow-up 7,323
Revised As Designed Catheters: Event Summary Table
Catheter Event Total
Catheter occlusion 14
Catheter dislodgement 8
Catheter kink 4
Catheter related complicationa 3
Catheter break/cut 2
Device connection issue 1
Pump unable to enter/withdraw from catheter access port 1
Total Catheter Events 33

a Includes 1 event reported as catheter malfunction, 1 possible catheter malfunction, and 1 inability to aspirate catheter.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.3%
(86.8%, 95.5%)
144
2 yrs 89.0%
(82.9%, 93.0%)
123
3 yrs 86.5%
(79.8%, 91.1%)
78
4 yrs 82.2%
(73.7%, 88.1%)
48
5 yrs 80.4%
(71.2%, 86.9%)
37
6 yrs 75.3%
(63.7%, 83.7%)
27
7 yrs 67.0%
(52.8%, 77.8%)
22
8 yrs 67.0%
(52.8%, 77.8%)
20

Ascenda Revised As Designed Catheters: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Ascenda Revised As Designed Catheters: Survival from Catheter Events

View Larger Image


Catheter Characteristics
Model Name Ascenda Revised As Designed
FDA Approval Date Sept 2012
Catheters Enrolled 166
Catheters Currently Active in Study 118
Device Events 11
Cumulative Months of Follow-up 2,410
Ascenda Revised As Designed Catheters: Event Summary Table
Catheter Event Total
Catheter occlusion 3
Catheter dislodgement 2
Catheter break/cut 1
Catheter disconnection at pump 1
Catheter kink 1
Catheter leakage 1
Pump connector break/cut 1
Pump reservoir volume discrepancy 1
Total Catheter Events 11
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.6%
(86.2%, 96.1%)
90
2 yrs 91.1%
(83.7%, 95.2%)
41
at 30 mo 88.1%
(77.5%, 93.9%)
23

Revised Not As Designed Catheters: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Revised Not As Designed Catheters: Survival from Catheter Events

View Larger Image


Catheter Characteristics
Model Name Revised Not As Designed
FDA Approval Date NA
Catheters Enrolled 645
Catheters Currently Active in Study 286
Device Events 95
Cumulative Months of Follow-up 20,944
Revised Not As Designed Catheters: Event Summary Table
Catheter Event Total
Catheter occlusion 29
Catheter dislodgement 22
Catheter break/cut 14
Catheter kink 12
Catheter related complicationa 5
Catheter disconnection at pump 4
Catheter leakage 3
Pump unable to enter/withdraw from catheter access port 3
Catheter access port issue 1
Connector block problem 1
Pump reservoir volume discrepancy 1
Total Catheter Events 95

a Includes 2 events reported as catheter malfunction, 1 inability to aspirate catheter, 1 poor CSF flow, and 1 catheter wrapped in coils and knots.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 91.0%
(88.1%, 93.2%)
441
2 yrs 87.6%
(84.4%, 90.3% )
356
3 yrs 84.2%
(80.4%, 87.3%)
263
4 yrs 82.4%
(78.3%, 85.7%)
186
5 yrs 80.7%
(76.2%, 84.4%)
115
6 yrs 71.8%
(64.6%, 77.8%)
63
7 yrs 65.2%
(56.4%, 72.7%)
37
8 yrs 62.5%
(52.4%, 71.1%)
21

Grafted Not As Designed Catheters: Survival from Catheter Events

Data are shown if there are at least 20 devices in each 3-month interval.

Grafted Not As Designed: Survival from Catheter Events

View Larger Image


Catheter Characteristics
Model Name Grafted Not As Designed
FDA Approval Date NA
Catheters Enrolled 445
Catheters Currently Active in Study 180
Device Events 72
Cumulative Months of Follow-up 14,426
Grafted Not As Designed Catheters: Event Summary Table
Catheter Event Total
Catheter dislodgement 25
Catheter occlusion 18
Catheter break/cut 10
Catheter leakage 4
Catheter related complicationa 4
Catheter kink 3
Pump unable to enter/withdraw from catheter access port 3
Catheter access port issue 1
Catheter disconnection at pump 1
Device component issueb 1
Device malfunction 1
Pump connector break/cut 1
Total Catheter Events 72

a Includes 3 events reported as inability to aspirate catheter, and 1 catheter malfunction.
b Reported as broken anchor attributed to the catheter.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 90.3%
(86.6%, 93.0%)
267
2 yrs 84.5%
(79.9%, 88.1%)
207
3 yrs 81.4%
(76.3%, 85.4%)
158
4 yrs 78.2%
(72.5%, 82.9%)
97
5 yrs 75.5%
(69.2%, 80.8%)
64
6 yrs 71.9%
(64.5%, 78.1%)
47
7 yrs 68.8%
(60.2%, 75.8%)
43
8 yrs 68.8%
(60.2%, 75.8%)
37
9 yrs 65.0%
(55.3%, 73.1%)
28
at 117 mo 65.0%
(55.3%, 73.1%)
21

Catheter Survival Summary TableCatheter Survival Summary Table

Catheter Characteristics
Model Number Family FDA Approval
Date
Catheters
Enrolled
Catheters
Currently
Active in Study
Device
Eventsa
Cumulative Months
of Follow-up
8709b 8709 May
1998
2,833 288 309 81,797
8709SC 8709 Mar
2006
1,036 291 115 32,258
8711 8711 Oct
1999
652 156 86 23,973
8731 8731 Oct
2002
503 71 50 20,109
8731SC 8731 Mar
2006
222 110 16 5,786
8780 Ascenda Sept
2012
701 500 44 9,810
8781 Ascenda Sept
2012
607 346 50 5,749
Revised As Designed NA Oct
2002
217 75 33 7,323
Ascenda Revised As Designed NA Sept
2012
166 118 11 2,410
Revised Not As Designed NA NA 645 286 95 20,944
Grafted Not As Designed NA NA 445 180 72 14,426

a There were a total of 1,064 catheter-related events reported to the registry, but only 881 events included in this summary table. The remaining catheter-related events either occurred in catheter models for which no device survival curves are presented due to an insufficient number of enrolled devices (n=22), or in catheters for which no model information was provided (n=22), or were subsequent events (i.e. additional events that occurred after the survival censoring event)  that did not affect the device survival estimates.
b Includes 8709 and 8709AA Models.

 

Device Survival Probability (95% Confidence Intervals)Table 1 of 3
Model Number 1 yr 2 yrs 3 yrs 4 yrs 5 yrs
8709 92.1%
(90.4%,
93.5%)
89.4%
(87.4%,
91.1%)
86.1%
(83.9%,
88.0%)
83.2%
(80.8%,
85.3%)
80.6%
(78.0%,
82.9%)
8709SC 93.9%
(92.0%,
95.4%)
89.4%
(86.9%,
91.5%)
87.1%
(84.3%,
89.4%)
83.9%
(80.7%,
86.7%)
82.2%
(78.6%,
85.2%)
8711 92.5%
(88.9%,
94.9%)
90.0%
(86.1%,
92.9%)
84.9%
(80.4%,
88.4%)
82.7%
(78.0%,
86.5%)
81.6%
(76.7%,
85.5%)
8731 93.6%
(88.8%,
96.3%)
92.3%
(87.5%,
95.3%)
91.3%
(86.5%,
94.4%)
89.3%
(84.3%,
92.8%)
87.7%
(82.4%,
91.5%)
8731SC 94.8%
(89.9%,
97.4%)
91.3%
(85.0%,
95.0%)
90.0%
(83.0%,
94.2%)
88.3%
(80.4%,
93.2%)
86.2%
(76.9%,
91.9%)
8780 93.4%
(90.8%,
95.3%)
90.5%
(87.1%,
93.0%)
89.6%
(85.7%,
92.5%)
- -
8781 87.6%
(83.4%,
90.8%)
85.5%
(80.5%,
89.3%)
- - -
Revised As Designed 92.3%
(86.8%,
95.5%)
89.0%
(82.9%,
93.0%)
86.5%
(79.8%,
91.1%)
82.2%
(73.7%,
88.1%)
80.4%
(71.2%,
86.9%)
Ascenda Revised As Designed 92.6%
(86.2%,
96.1%)
91.1%
(83.7%,
95.2%)
- - -
Revised Not As Designed 91.0%
(88.1%,
93.2%)
87.6%
(84.4%,
90.3%)
84.2%
(80.4%,
87.3%)
82.4%
(78.3%,
85.7%)
80.7%
(76.2%,
84.4%)
Grafted Not As Designed 90.3%
(86.6%,
93.0%)
84.5%
(79.9%,
88.1%)
81.4%
(76.3%,
85.4%)
78.2%
(72.5%,
82.9%)
75.5%
(69.2%,
80.8%)

 

Device Survival Probability (95% Confidence Intervals)Table 2 of 3
Model Number 6 yrs 7 yrs 8 yrs 9 yrs 10 yrs
8709 76.0%
(73.1%,
78.6%)
71.3%
(68.2%,
74.2%)
68.9%
(65.6%,
72.0%)
67.4%
(63.9%,
70.6%)
65.2%
(61.5%,
68.7%)
8709SC 81.1%
(77.2%,
82.2%)
76.4%
(71.0%,
81.0%)
76.4%
(71.0%,
81.0%)
- -
8711 77.7%
(72.3%,
82.2%)
74.1%
(68.3%,
79.1%)
71.7%
(65.5%,
76.9%)
69.8%
(63.2%,
75.5%)
65.9%
(58.1%,
72.5%)
8731 82.3%
(76.1%,
87.0%)
78.7%
(71.9%,
84.0%)
76.0%
(68.6%,
81.8%)
74.8%
(67.2%,
80.9%)
74.8%
(67.2%,
80.9%)
8731SC 86.2%
(76.9%,
91.9%)
- - - -
8780 - - - - -
8781 - - - - -
Revised As Designed 75.3%
(63.7%,
83.7%)
67.0%
(52.8%,
77.8%)
67.0%
(52.8%,
77.8%)
- -
Ascenda Revised As Designed - - - - -
Revised Not As Designed 71.8%
(64.6%,
77.8%)
65.2%
(56.4%,
72.7%)
62.5%
(52.4%,
71.1%)
- -
Grafted Not As Designed 71.9%
(64.5%,
78.1%)
68.8%
(60.2%,
75.8%)
68.8%
(60.2%,
75.8%)
65.0%
(55.3%,
73.1%)
-

 

Device Survival Probability (95% Confidence Intervals)Table 3 of 3
Model Number 11 yrs 12 yrs 13 yrs 14 yrs 15 yrs
8709 62.7%
(58.6%,
66.5%)
60.1%
(55.5%,
64.3%)
57.7%
(52.5%,
62.5%)
57.7%
(52.5%,
62.5%)
55.7%
(49.4%,
61.6%)
8709SC - - - - -
8711 62.6%
(53.9%,
70.2%)
60.6%
(51.1%,
68.7%)
57.9%
(47.3%,
67.0%)
- -
8731 72.8%
(64.2%,
79.7%)
- - - -
8731SC - - - - -
8780 - - - - -
8781 - - - - -
Revised As Designed - - - - -
Ascenda Revised As Designed - - - - -
Revised Not As Designed - - - - -
Grafted Not As Designed - - - - -

 

2016 Medtronic Product Performance Report: Data through July 31, 2016.

United States