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Spinal Cord Stimulation Systems

Spinal Cord Stimulation Systems
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Study Participants

Centers

The following spinal cord stimulation tables and graphs were generated based on data collected between June 2004 and the report cut-off date of July 31, 2014.  Sixty-nine centers enrolled and contributed patients to the spinal cord stimulation section of the report.


Patients

Of the 3,204 total spinal cord stimulation patients enrolled, 45.6% were implanted for the treatment of other pain indications, 41.9% were implanted for the treatment of failed back pain, 10.8% were implanted for the treatment of complex regional pain syndrome (CRPS), and 1.7% were implanted for  indications that were not specified in the database.

Primary SCS Treatment IndicationsPrimary SCS Treatment Indications

Primary SCS System Treatment Indications Chart
Primary Treatment Indicationa Total Enrolled Patients (Percent)
Other 1,462 (45.6%)
Radicular pain syndrome 420 (13.1%)
Degenerative disc disease 121 (3.8%)
Cervical pain 22 (0.7%)
Diabetic neuropathy 15 (0.5%)
Traumatic nerve injury 11 (0.3%)
Post Herpetic Neuralgia 7 (0.2%)
Facial pain 5 (0.2%)
Epidural Fibrosis 2 (<0.1%)
Post herniorrhaphy pain 1 (<0.1%)
Other chronic pain 635 (19.8%)
Other 223 (7.0%)
Failed Back Pain 1,343 (41.9%)
Postlaminectomy pain 584 (18.2%)
Failed Back Syndrome (FBS) 456 (14.2%)
Combination back and leg pain 208 (6.5%)
Multiple Back Operations 68 (2.1%)
Arachnoiditis 21 (0.7%)
Unsuccessful Disc Surgery 6 (0.2%)
CRPS 346 (10.8%)
CRPS I 262 (8.2%)
CRPS II 84 (2.6%)
Not Specified 53 (1.7%)
Total Patients 3,204

a Refer to product labeling for approved indications.

 

Event Summary

There were 1,728 events reported between June 2004 and July 31, 2014 in patients with spinal cord stimulation systems. Over forty-two percent of these events (730/1,728) were categorized as product performance-related and are presented graphically within this report. The 730 product performance events occurred in 331 of the 3,204 total patients (10.33%) enrolled. In addition, there were 998 non-product performance events. There were also 86 deaths reported for patients with neurostimulation systems, none of which were reported as a direct result of a device-related event or the stimulation therapy.  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.

Neurostimulation System Product Performance Events
Eventa Number of Product
Performance
Events
Number of Patients with Eventb Percent of Patients with Event
(n=3,204)
Lead migration/dislodgment 377 192 5.99%
Lead high impedance 129 53 1.65%
Lead fracture 50 34 1.06%
Device stimulation issuec 45 25 0.78%
Lead low impedance 26 7 0.22%
Neurostimulator unable to recharged 20 18 0.56%
Medical device complicatione 15 10 0.31%
Extension fracture 13 8 0.25%
Device breakagef 12 12 0.37%
Device malfunctiong 12 10 0.31%
Device connection issue 7 1 0.03%
Device lead damage 7 5 0.16%
Device failureh 4 3 0.09%
Device component issuei 3 2 0.06%
Not Codedj 2 1 0.03%
Paraesthesiak 2 2 0.06%
Therapeutic product ineffective 2 1 0.03%
Antenna cable breakage 1 1 0.03%
Battery recharge issue 1 1 0.03%
Broken bond wire 1 1 0.03%
Device battery issue 1 1 0.03%
Total 730 331 10.33%

a Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
b The total number of patients may not represent the sum of all rows, as a patient may have experienced more than one type of event.
c Device stimulation issue reported by physician as being caused by neurostimulator (n=2) or lead (n=43).
d There were a total of 1,914 patients that used rechargeable SCS neurostimulators in the registry.  A total of 1.0% (20/1,914) of patients with a rechargeable SCS neurostimulator experienced a recharging unable to recharge event.
e Includes  4 leads no longer providing stimulation, 3 error messages on patient programmer, 2 events reported as unable to pass stylet into lead, 2 leads with open circuits, 1 unknown problem with extension, 1 defective patient programmer, 1 excessive heating of charging unit, and 1 hybrid anomaly.
f Includes 6 broken recharger belts, 1 broken antenna, 1 broken antenna and jack, 1 broken charger, 1 broken patient programmer, 1 frayed cord to recharge antenna, and 1 frayed wire to recharger.
g Includes 3 neurostimulator malfunctions, 2 events for impedance not measurable, 2 events for non-functional lead electrodes , 1 antenna malfunction, 1 malfunctioning programmer, 1 event for lead impedance changes, 1 event for error messages on programmer, and 1 event for neurostimulator stopped working abruptly.
h Includes 2 events for lead failure, 1 event for failure of lead electrodes, and 1 extension failure.
i Includes 2 events for lead fractures and migration and 1 faulty antenna.
j Includes 2 events for malfunction in leads.
k Includes 1 event for shocking sensation at battery site and 1 shocking sensation at battery/extension connection.

A total of 640 (87.7%) of the 730 product performance events were related to the lead, 29 (4.0%) were related to "other device", 22 (3.0%) were related to the extension, 17 (2.3%) were related to the neurostimulator, 10 (1.4%) were related to recharging process, 6 (0.8%) were related to programming/stimulation, 2 (0.3%) was related to incisional site/device tract, 2 (0.3%) were related to other etiology, and 2 (0.3%) were related to the procedure. Relatedness is determined by the physician.

Product Performance Events by Relatedness       

 

 

 

Product Performance Events by Relatedness     

 

 

 

 
Neurostimulation System Non-Product Performance Events (including adverse eventsa and device events, excluding deaths and normal battery depletions)
Eventsb Number of Non-Product Performance Events
Device issues 301
   Device stimulation issuec 150
   Neurostimulator unable to recharged 78
   Neurostimulator migration 31
   Device battery issuee 6
   Device use error 5
   Otherf 31
Administration site reactions 242
   Implant site pain 115
   Implant site infection 70
   Implant site erythema 15
   Implant site erosion 13
   Implant site extravasation 11
   Otherf 18
Therapeutic and nontherapeutic effects (excluding toxicity) 234
   Therapeutic product ineffective 112
   Therapeutic response decreased 60
   No therapeutic response 58
   Otherf 4
General system disorders not elsewhere classified (NEC) 52
   Pain 47
   Otherf 5
Procedural related injuries and complications NEC 35
   Wound dehiscence 7
   Incision site pain 5
   Otherf 23
Musculoskeletal and connective tissue disorders NEC 27
   Pain in extremity 15
   Back pain 8
   Otherf 4
Complications associated with device 19
   Medical device discomfort 14
   Otherf 5
Infections - pathogen unspecified 19
   Infection 9
   Wound infection 7
   Otherf 3
Neurological disorders NEC 19
   Paraesthesia 11
   Otherf 8
Not Codedg 6
Otherf 44
Total 998

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
c Event reported by the physician with an etiology that was not device related.
d Patient was unable to recharge due to an issue not related to the device.
e Includes 4 events reported as difficulty recharging neurostimulator, 1 unable to fully charge neurostimulator, and 1 unable to charge neurostimulator not due to the neurostimulator.
f Composed of event codes with fewer than 5 events each.
g Events were not coded at the time of data cut-off.  Reported as1 unsatisfactory SCS analgesia secondary to lead migration, 1 malpositioned generator, 1 inadequate coverage, 1 possible connection issues, 1 abnormal system continuity check, and 1 not specified.

There were 86 deaths reported for patients with neurostimulation systems, none of which were reported as a direct result of a device-related event or the stimulation therapy.  As indicated, 46 (53.5%) of deaths occurred in patients receiving therapy for pain indications in the "other" category, 35 (40.7%) for failed back, and 5 (5.8%) for CRPS.

Death by Primary Indication
Primary Indicationa N (%)
CRPS 5 (5.8%)
Failed Back 35 (40.7%)
Other 46 (53.5%)
Total 86 (100%)

a Refer to product labeling for approved indications

Spinal Cord Stimulators

From June 2004 to the report cut-off date of July 31, 2014, 3,521 spinal cord stimulators were followed in the registry. The difference between the total number of patients (N=3,204) versus spinal cord stimulators is due to the fact that some patients had multiple spinal cord stimulators or were subsequently re-implanted. The aggregate prospective follow-up time for all spinal cord stimulators was 56,203 months (4,684 years). The table below provides the number and percentage of spinal cord stimulators by model.

Spinal Cord Stimulators by Model
Model Name Number of Spinal Cord Stimulators (%)
PrimeAdvanced 633 (18.0%)
RestoreUltra 579 (16.4%)
Synergy 461 (13.1%)
Restore 447 (12.7%)
RestoreAdvanced 360 (10.2%)
RestoreSensor 309 (8.8%)
RestoreSensor SureScan MRI 293 (8.3%)
PrimeAdvanced SureScan MRI 128 (3.6%)
Itrel 3 96 (2.7%)
RestorePrime 58 (1.6%)
Synergy Versitrel 42 (1.2%)
Itrel 4 32 (0.9%)
RestoreAdvanced SureScan MRI 29 (0.8%)
Other/Unspecified 18 (0.5%)
SynergyPlus+ 16 (0.5%)
RestoreUltra SureScan MRI 12 (0.3%)
SynergyCompact 8 (0.2%)
Total 3,521 (100%)

Spinal Cord Stimulator Events Spinal Cord Stimulator Events

There were 17 product performance-related events with an underlying reported etiology related to spinal cord stimulator function. Of these, 13 were the first event attributable to an enrolled stimulator. For spinal cord stimulators in the registry, the current return rate to Medtronic Returned Product Analysis (RPA) was 213/809 (26.3%). The proportion was based upon the number of registry spinal cord stimulators received by RPA, divided by the total number of explanted devices plus the total number of spinal cord stimulation devices in patients who have expired. One of the 17 spinal cord stimulator events was confirmed by Medtronic RPA as a broken bond wire. The remaining 16 spinal cord stimulators with performance-related events were not returned to Medtronic RPA but were assigned as device related by the physician due to medical device complication (n=3), neurostimulator unable to recharge (n=3), lead high impedance (n=3), device malfunction (n=3), device stimulation issue (n=2), device battery issue (n=1), or device connection issue (n=1).

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 spinal cord stimulators:

  • 13 had follow-up time cut-off due to product performance-related events.
  • 1,960 were censored in the survival analysis for the following reasons: patient expired, stimulator explanted, site termination, patient discontinued, other stimulator modification, therapy suspended, or non-product performance stimulator-related event without an associated intervention.
  • 1,548 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Spinal Cord Stimulator SurvivalSpinal Cord Stimulator Survival

The figures and tables below represent spinal cord stimulator survival and 95% confidence intervals where at least 20 spinal cord stimulators contributed to each 3-month interval.  Currently, estimates of device survival from neurostimulator-related events exceed 97% (confidence intervals exceed 87%) for all neurostimulator models at the applicable follow-up time points that include at least 20 active devices.

               

Model 7425 Itrel 3: Survival from Spinal Cord Stimulator Events

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

Model 7425 Itrel 3: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name Itrel 3
FDA Approval Date Aug 1995
Neurostimulators Enrolled 96
Neurostimulators Currently Active in Study 0
Device Events 0
Cumulative Months of Follow-up 1,360
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 35
2 yrs 100.0% (NA) 23
at 30 mo 100.0% (NA) 21

 

Model 7425 Itrel 3: Specifications

Height 2.2 in (55 mm) ppr-8627-18
Width 2.4 in (60 mm)
Thinness 0.4 in (10 mm)
Volume 22 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use (additional Information)
Maximum Electrodes 4
Amplitude 0 - 10.5 V
Rate 2.1 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 1
Programs 1
Implant Depth ≤ 4 cm

Model 7427 Synergy: Survival from Spinal Cord Stimulator Events

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

Model 7427 Synergy: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name Synergy
FDA Approval Date Nov 1999
Neurostimulators Enrolled 461
Neurostimulators Currently Active in Study 16
Device Events 2
Cumulative Months of Follow-up 8,778
Model 7427 Synergy: Event Summary Table
Neurostimulator Event Total
Device stimulation issue 1
Broken bond wire 1
Total Neurostimulator Events 2
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 202
2 yrs 100.0% (NA) 166
3 yrs 100.0% (NA) 112
4 yrs 99.1%
(93.6%, 99.9%)
73
5 yrs 97.6%
(90.6%, 99.4%)
43
6 yrs 97.6%
(90.6%, 99.4%)
28
at 81 mo 97.6%
(90.6%, 99.4%)
20

 

Model 7427 Synergy: Specifications

Height 2.4 in (61 mm) ppr-7427
Width 3.0 in (76 mm)
Thinness 0.6 in (15 mm)
Volume 51 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use (additional Information)
Maximum Electrodes 8
Amplitude 0 - 10.5 V
Rate 3 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 1
Programs 2
Implant Depth ≤ 4 cm

Model 37701 RestorePrime: Survival from Spinal Cord Stimulator Events

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

Model 37701 RestorePrime: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name RestorePrime
FDA Approval Date Mar 2006
Neurostimulators Enrolled 58
Neurostimulators Currently Active in Study 3
Device Events 0
Cumulative Months of Follow-up 1,237
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 35
2 yrs 100.0% (NA) 24
at 27 mo 100.0% (NA) 22

 

Model 37701 RestorePrime: Specifications

Height 2.6 in (65 mm) ppr-37701
Width 1.9 in (49 mm)
Thinness 0.6 in (15 mm)
Volume 39 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use (additional Information)
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 4
Implant Depth ≤ 4 cm

Model 37702 PrimeAdvanced: Survival from Spinal Cord Stimulator Events

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

Model 37702 PrimeAdvanced: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name PrimeAdvanced
FDA Approval Date Jul 2006
Neurostimulators Enrolled 633
Neurostimulators Currently Active in Study 168
Device Events 1
Cumulative Months of Follow-up 9,329
Model 37702 PrimeAdvanced: Event Summary Table
Neurostimulator Event Total
Device stimulation issue 1
Total Neurostimulator Events 1
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.8%
(98.2%,100.0%)
293
2 yrs 99.8%
(98.2%,100.0%)
140
3 yrs 99.8%
(98.2%,100.0%)
64
4 yrs 99.8%
(98.2%,100.0%)
21

 

Model 37702 PrimeAdvanced: Specifications

Height 2.6 in (65 mm) ppr-37702
Width 1.9 in (49 mm)
Thinness 0.6 in (15 mm)
Volume 39 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use (additional Information)
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 32
Implant Depth ≤ 4 cm

Model 37711 Restore: Survival from Spinal Cord Stimulator Events

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

Model 37711 Restore: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name Restore
FDA Approval Date Apr 2005
Neurostimulators Enrolled 447
Neurostimulators Currently Active in Study 40
Device Events 3
Cumulative Months of Follow-up 11,958
Model 37711 Restore: Event Summary Table
Neurostimulator Event Total
Neurostimulator unable to recharge 2
Device battery issue 1
Total Neurostimulator Events 3
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 267
2 yrs 100.0% (NA) 216
3 yrs 100.0% (NA) 139
4 yrs 100.0% (NA) 80
5 yrs 100.0% (NA) 63
6 yrs 98.1%
(87.2%, 99.7%)
47
7 yrs 98.1%
(87.2%, 99.7%)
32
at 93 mo 98.1%
(87.2%, 99.7%)
20

 

Model 37711 Restore: Specifications

Height 2.6 in (65 mm) ppr-37711
Width 1.9 in (49 mm)
Thinness 0.6 in (15 mm)
Volume 39 cc
Battery type Rechargeable
Expected Battery life 9 years
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 32
Implant Depth ≤ 1 cm

Model 37713 RestoreAdvanced: Survival from Spinal Cord Stimulator Events

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

Model 37713 RestoreAdvanced: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name RestoreAdvanced
FDA Approval Date Jul 2006
Neurostimulators Enrolled 360
Neurostimulators Currently Active in Study 123
Device Events 1
Cumulative Months of Follow-up 8,012
Model 37713 RestoreAdvanced: Event Summary Table
Neurostimulator Event Total
Medical device complicationa 1
Total Neurostimulator Events 1

a One event reported as hybrid anomaly

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.6%
(97.4%, 99.9%)
203
2 yrs 99.6%
(97.4%, 99.9%)
129
3 yrs 99.6%
(97.4%, 99.9%)
75
4 yrs 99.6%
(97.4%, 99.9%)
54
5 yrs 99.6%
(97.4%, 99.9%)
32
6 yrs 99.6%
(97.4%, 99.9%)
20

 

Model 37713 RestoreAdvanced: Specifications

Height 2.6 in (65 mm) ppr-37713
Width 1.9 in (49 mm)
Thinness 0.6 in (15 mm)
Volume 39 cc
Battery type Rechargeable
Expected Battery life 9 years
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 32
Implant Depth ≤ 1 cm

Model 37712 RestoreUltra: Survival from Spinal Cord Stimulator Events

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

Model 37712 RestoreUltra: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name RestoreUltra
FDA Approval Date Jan 2008
Neurostimulators Enrolled 579
Neurostimulators Currently Active in Study 146
Device Events 4
Cumulative Months of Follow-up 10,802
Model 37712 RestoreUltra: Event Summary Table
Neurostimulator Event Total
Device malfunctiona 2
Lead high impedance 1
Medical device complicationb 1
Total Neurostimulator Events 4

a One event reported as malfunction of the spinal cord stimulation system and 1 as problems with reprogramming
b Error message on patient programmer

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.8%
(98.5%, 100.0%)
291
2 yrs 98.7%
(95.9%, 99.6%)
168
3 yrs 98.7%
(95.9%, 99.6%)
112
4 yrs 97.5%
(92.1%, 99.2%)
66
5 yrs 97.5%
(92.1%, 99.2%)
23

 

Model 37712 RestoreUltra: Specifications

Height 2.1 in (54 mm) ppr-37712
Width 2.1 in (54 mm)
Thinness 0.4 in (10 mm)
Volume 22 cc
Battery type Rechargeable
Expected Battery life 9 years
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 1200 Hz
Pulse Width 60 - 1000 μsec
Groups 8
Programs 16
Implant Depth ≤ 1 cm

Model 37714 RestoreSensor: Survival from Spinal Cord Stimulator Events

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

Model 37714 RestoreSensor: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name RestoreSensor
FDA Approval Date Nov 2011
Neurostimulators Enrolled 309
Neurostimulators Currently Active in Study 239
Device Events 2
Cumulative Months of Follow-up 2,632
Model 37714 RestoreSensor: Event Summary Table
Neurostimulator Event Total
Device malfunctiona 1
Neurostimulator unable to recharge 1
Total Neurostimulator Events 2

a One event reported as neurostimulator malfunction

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 98.9%
(95.5%, 99.7%)
94
at 21 mo 98.9%
(95.5%, 99.7%)
31

 

Model 37714 RestoreSensor: Specifications

Height 2.1 in (54 mm) ppr-37714
Width 2.1 in (54 mm)
Thinness 0.4 in (9 mm)
Volume 22 cc
Battery type Rechargeable
Expected Battery life 9 years
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 1200 Hz
Pulse Width 60 - 1000 μsec
Groups 8
Programs 16
Implant Depth ≤ 1 cm

Spinal Cord Stimulator Survival Summary Spinal Cord Stimulator Survival Summary

Currently, estimates of device survival from neurostimulator-related events exceed 97% (confidence intervals exceed 87%) for all neurostimulator models at the applicable follow-up time points that include at least 20 active devices.

Spinal Cord Stimulator Characteristics
Model Name Family FDA
Approval
Date
Neuro-
stimulators
Enrolled
Neuro-
stimulators
Currently
Active in
Study
Device
Eventsa
Cumulative
Months of
Follow-up
Primary Cell Neurostimulators
Itrel 3 Itrel 3 Aug
1995
96 0 0 1,360
Synergy Synergy Nov
1999
461 16 2 8,778
Restore
Prime
Restore Mar
2006
58 3 0 1,237
Prime
Advanced
Prime
Advanced
Jul
2006
633 168 1 9,329
Rechargeable Neurostimulators
Restore Restore Apr
2005
447 40 3 11,958
Restore
Advanced
Restore Jul
2006
360 123 1 8,012
Restore
Ultra
Restore Jan
2008
579 146 4 10,802
Restore
Sensor
Restore Nov
2011
309 239 2 2,632

a There were 17 neurostimulator-related events reported to the registry, but only 13 events included in this summary table. The remaining neurostimulator-related events were subsequent events that did not affect the device survival estimates.

Device Survival Probability (95% Confidence Interval)Table 1 of 2
Model Name 1 yr 2 yrs 3 yrs 4 yrs
Primary Cell Neurostimulators
Itrel 3 100.0%
NA
100.0%
NA
- -
Synergy 100.0%
NA
100.0%
NA
100.0%
NA
99.1%
(93.6%, 99.9%)
RestorePrime 100.0%
NA
100.0%
NA
- -
PrimeAdvanced 99.8%
(98.2%, 100.0%)
99.8%
(98.2%, 100.0%)
99.8%
(98.2%, 100.0%)
99.8%
(98.2%, 100.0%)
Rechargeable Neurostimulators
Restore 100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
RestoreAdvanced 99.6%
(97.4%, 99.9%)
99.6%
(97.4%, 99.9%)
99.6%
(97.4%, 99.9%)
99.6%
(97.4%, 99.9%)
RestoreUltra 99.8%
(98.5%, 100.0%)
98.7%
(95.9%, 99.6%)
98.7%
(95.9%, 99.6%)
97.5%
(92.1%, 99.2%)
RestoreSensor 98.9%
(95.5%, 99.7%)
- - -
Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Name 5 yrs 6 yrs 7 yrs
Primary Cell Neurostimulators
Itrel 3 - - -
Synergy 97.6%
(90.6%, 99.4%)
97.6%
(90.6%, 99.4%)
-
RestorePrime - - -
PrimeAdvanced - - -
Rechargeable Neurostimulators
Restore 100.0%
NA
98.1%
(87.2%, 99.7%)
98.1%
(87.2%, 99.7%)
RestoreAdvanced 99.6%
(97.4%, 99.9%)
99.6%
(97.4%, 99.9%)
-
RestoreUltra 97.5%
(92.1%, 99.2%)
- -
RestoreSensor - - -

Leads

From June 2004 to the report cut-off date of July 31, 2014, there were 5,998 leads followed in the registry. Differences between the total number of leads versus spinal cord stimulators (N=3,521) were due to the fact that some patients were subsequently re-implanted with a new lead or were implanted with more than 1 lead. The aggregate prospective follow-up time for all leads was 103,974 months (8,665 years).

A lead is a set of thin wires with a protective coating and electrodes near the tip (percutaneous lead) or on a paddle (surgical lead). The table below provides the number and percentage of leads by model.

Leads by Model
Model Number Number of Leads (%)
3778 2,095 (34.9%)
3487A 880 (14.7%)
3777 764 (12.7%)
977A2 608 (10.1%)
3888 383 (6.4%)
39565 178 (3.0%)
3776 172 (2.9%)
3887 164 (2.7%)
3998 142 (2.4%)
3890 128 (2.1%)
3891 117 (2.0%)
3986A 94 (1.6%)
3999 52 (0.9%)
3587A 48 (0.8%)
977A1 36 (0.6%)
3892 17 (0.3%)
39286 17 (0.3%)
3987A 7 (0.1%)
3982A 1 (<0.1%)
Other/Unspecified 95 (1.6%)
Total 5,998 (100%)

Over ninety percent (90.4%) of leads in the registry were percutaneous leads (5,423/5,998) including 50.5% (3,031/5,998) in the Pisces-Octad lead family, 23.8% (1,427/5,998) in the Pisces-Quad lead family, 10.7% (644/5,998) in the Vectris SureScan MRI lead family, and 4.4% (262/5,998) in the Pisces-Quad LZ lead family. Almost eight percent (8.0%) of leads (479/5,998) were surgical leads.  A small number of leads (96/5,998) were designated as Other (1.6%).

Lead EventsLead Events

There were 640 product performance-related events with an underlying reported etiology related to the lead. Of these events, the majority were lead migration/dislodgements (n=373), high impedance (n=119), and lead fracture (n=50). Of the 640 events, 547 were the first event attributable to an enrolled lead: 519 events in 5,423 (9.6%) percutaneous leads, 27 events in 479 (5.6%) surgical leads, and 1 event occurred in a lead with an unknown model number.

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 leads:

  • 547 had follow-up time cut-off due to product performance-related events.  
  • 2,683 were censored in the survival analysis for the following reasons: patient expired, lead explanted, site termination, patient discontinued, other lead modification, therapy suspended, or non-product performance lead-related event without an associated intervention.
  • 2,768 were free from product performance-related events and censoring events, were censored at the last follow-up prior to the report cut-off.

Lead SurvivalLead Survival

The figures and tables below represent lead survival and 95% confidence intervals where at least 20 leads 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. For surgical leads, currently the estimates of device survival from lead-related events exceed 87% (confidence intervals exceed 72%) at the applicable follow-up time points that include at least 20 active devices with the exception of model 3986A.

For percutaneous leads, currently the estimates of survival from lead-related events exceed 71% (confidence intervals exceed 61%) through 5 years of follow-up for applicable leads with follow-up through that time point.  At 2 years of follow-up, model 3891 estimates of device survival are less than 76% compared to other models which exceed 83% (confidence intervals exceed 68%). As of February 6, 2008, Medtronic has discontinued worldwide distribution of the Pisces-Quad LZ lead (Models 3890, 3891, and 3892) due to performance relative to other percutaneous leads and minimal commercial demand for the product.

                               
   

Model 3487A Pisces-Quad: Survival from Lead Events

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

Model 3487A: Survival from Lead Events

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Lead Characteristics
Model Number 3487A
FDA Approval Date May 1988
Leads Enrolled 880
Leads Currently Active in Study 319
Device Events 133
Cumulative Months of Follow-up 22,440
Model 3487A Pisces-Quad: Event Summary Table
Lead Event Total
Lead high impedance 50
Lead migration/dislodgment 35
Lead low impedance 21
Device stimulation issue 17
Lead fracture 10
Total Lead Events 133
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 90.5%
(87.5%, 92.8%)
404
2 yrs 87.6%
(84.2%, 90.3%)
314
3 yrs 81.8%
(77.7%, 85.2%)
254
4 yrs 74.9%
(70.0%, 79.1%)
187
5 yrs 71.5%
(66.2%, 76.1%)
133
6 yrs 68.5%
(62.7%, 73.5%)
105
7 yrs 66.2%
(60.1%, 71.7%)
75
8 yrs 66.2%
(60.1%, 71.7%)
48
9 yrs 66.2%
(60.1%, 71.7%)
40
10 yrs 62.9%
(55.4%, 69.6%)
37
11 yrs 60.9%
(52.4%, 68.3%)
25

 

Model 3487A Pisces-Quad: Specifications

Device Name Pisces Standard ppr-3487A
Lead Type Percutaneous
Lead
Length (cm) 28, 33, 45, 56
Diameter (mm) 1.3
Electrode
Number 4
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 6.0
Array Length (mm) 30.0

Model 3887 Pisces-Quad: Survival from Lead Events

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

Model 3887 Pisces-Quad: Survival from Lead Events

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Lead Characteristics
Model Number 3887
FDA Approval Date Jan 1997
Leads Enrolled 164
Leads Currently Active in Study 39
Device Events 15
Cumulative Months of Follow-up 3,765
Model 3887 Pisces-Quad: Event Summary Table
Lead Event Total
Lead fracture 7
Lead migration/dislodgment 3
Device stimulation issue 2
Lead high impedance 2
Device lead damage 1
Total Lead Events 15
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 95.6%
(72.4%, 99.4%)
43
2 yrs 84.4%
(68.9%, 92.6%)
47
3 yrs 80.6%
(65.2%, 89.7%)
43
4 yrs 78.9%
(63.5%, 88.3%)
41
5 yrs 76.7%
(61.2%, 86.6%)
34
6 yrs 73.9%
(57.9%, 84.6%)
26
at 81 mo 71.1% 
(54.8%, 82.5%)
21

 

Model 3887 Pisces-Quad: Specifications

Device Name Pisces Compact ppr-3887
Lead Type Percutaneous
Lead
Length (cm) 28, 33, 45, 56
Diameter (mm) 1.3
Electrode
Number 4
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 4.0
Array Length (mm) 24.0

Model 3888 Pisces-Quad: Survival from Lead Events

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

Model 3888 Pisces-Quad: Survival from Lead Events

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Lead Characteristics
Model Number 3888
FDA Approval Date Nov 1992
Leads Enrolled 383
Leads Currently Active in Study 61
Device Events 24
Cumulative Months of Follow-up 6,608
Model 3888 Pisces-Quad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 21
Device stimulation issue 2
Lead fracture 1
Total Lead Events 24
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.0%
(87.0%, 95.1%)
116
2 yrs 90.2%
(84.6%, 93.9%)
65
3 yrs 84.1%
(75.3%, 90.0%)
58
4 yrs 82.6%
(73.3%, 88.9%)
49
5 yrs 79.2%
(68.9%, 86.4%)
43
6 yrs 79.2%
(68.9%, 86.4%)
26
7 yrs 79.2%
(68.9%, 86.4%)
22
8 yrs 79.2%
(68.9%, 86.4%)
21
at 102 mo 79.2%
(68.9%, 86.4%)
20

 

Model 3888 Pisces-Quad: Specifications

Device Name Pisces Plus ppr-3888
Lead Type Percutaneous
Lead
Length (cm) 28, 33, 45, 56
Diameter (mm) 1.3
Electrode
Number 4
Shape Cylindrical
Length (mm) 6.0
Individual Surface Area (mm) 24.0
Inter-Electrode Spacing: Edge to Edge (mm) 12.0
Array Length (mm) 60.0

Model 3890 Pisces-Quad LZ: Survival from Lead Events

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

Model 3890 Pisces-Quad LZ: Survival from Lead Events

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Note: As of February 6, 2008, Medtronic discontinued worldwide distribution of the Pisces Quad LZ lead due to performance relative to other percutaneous leads and minimal commercial demand for the product.
Lead Characteristics
Model Number 3890
FDA Approval Date Sep 2002
Leads Enrolled 128
Leads Currently Active in Study 8
Device Events 10
Cumulative Months of Follow-up 2,561
Model 3890 Pisces-Quad LZ: Event Summary Table
Lead Event Total
Lead migration/dislodgment 4
Device malfunctiona 2
Lead fracture 2
Lead high impedance 2
Total Lead Events 10

a Two events reported as impedance not measurable

 
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 38
2 yrs 97.7%
(84.8%, 99.7%)
48
3 yrs 89.0%
(75.6%, 95.3%)
38
4 yrs 89.0%
(75.6%, 95.3%)
31
5 yrs 82.7%
(66.5% ,91.5%)
22
at 63 mo 82.7%
(66.5%, 91.5%)
20

 

Model 3890 Pisces-Quad LZ: Specifications

Device name Pisces Z Quad ppr-3890
Lead Type Percutaneous
Lead
Length (cm) 10 - 100
Diameter (mm) 1.3
Electrode
Number 4
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 3.0
Array Length (mm) 30.0

Model 3891 Pisces-Quad LZ: Survival from Lead Events

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

Model 3891 Pisces-Quad LZ: Survival from Lead Events

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Note: As of February 6, 2008, Medtronic discontinued worldwide distribution of the Pisces Quad LZ lead due to performance relative to other percutaneous leads and minimal commercial demand for the product.
Lead Characteristics
Model Number 3891
FDA Approval Date Sep 2002
Leads Enrolled 117
Leads Currently Active in Study 6
Device Events 30
Cumulative Months of Follow-up 1,860
Model 3891 Pisces-Quad LZ: Event Summary Table
Lead Event Total
Lead migration/dislodgment 18
Lead fracture 6
Device stimulation issue 4
Device lead damage 2
Total Lead Events 30
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 78.9%
(67.5%, 86.8%)
47
2 yrs 75.5%
(63.4%, 84.1%)
35
at 30 mo 61.1% 
(46.5%, 72.9%)
21

 

Model 3891 Pisces-Quad LZ: Specifications

Device Name Pisces Z
Quad Compact
ppr-3891
Lead Type Percutaneous
Lead
Length (cm) 10 - 100
Diameter (mm) 1.3
Electrode
Number 4
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 3.0
Array Length (mm) 24.0

Model 3776 Pisces-Octad: Survival from Lead Events

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

Model 3776 Pisces-Octad: Survival from Lead Events

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Lead Characteristics
Model Number 3776
FDA Approval Date Nov 2005
Leads Enrolled 172
Leads Currently Active in Study 49
Device Events 4
Cumulative Months of Follow-up 2,941
Model 3776 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 7
Device stimulation issue 1
Lead fracture 1
Total Lead Events 9
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 93.4%
(87.2%, 96.6%)
71
2 yrs 93.4%
(87.2%, 96.6%)
42
3 yrs 93.4%
(87.2%, 96.6%)
30
4 yrs 90.2%
(79.5%, 95.5%)
21

 

Model 3776 Pisces-Octad: Specifications

Device Name 1x8
Sub-compact
ppr-3776
Lead Type Percutaneous
Lead
Length (cm) 45, 60, 75
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 1.5
Array Length (mm) 35.0

Model 3777 Pisces-Octad: Survival from Lead Events

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

Model 3777 Pisces-Octad: Survival from Lead Events

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Lead Characteristics
Model Number 3777
FDA Approval Date Apr 2005
Leads Enrolled 764
Leads Currently Active in Study 188
Device Events 48
Cumulative Months of Follow-up 13,361
Model 3777 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 35
Device stimulation issue 7
Lead high impedance 3
Device lead damage 2
Lead fracture 1
Total Lead Events 48
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.5%
(89.5%, 94.6%)
330
2 yrs 88.5%
(84.8%, 91.4%)
211
3 yrs 88.5%
(84.8%, 91.4%)
129
4 yrs 88.5%
(84.8%, 91.4%)
72
5 yrs 87.2%
(82.4%, 90.7%)
51
6 yrs 83.5%
(75.9%, 88.9%)
41
7 yrs 83.5%
(75.9%, 88.9%)
24
at 90 mo 83.5%
(75.9%, 88.9%)
24

 

Model 3777 Pisces-Octad: Specifications

Device Name 1x8
Standard
ppr-3777
Lead Type Percutaneous
Lead
Length (cm) 45, 60, 75
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 6.0
Array Length (mm) 66.0

Model 3778 Pisces-Octad: Survival from Lead Events

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

Model 3778 Pisces-Octad: Survival from Lead Events

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Lead Characteristics
Model Number 3778
FDA Approval Date Apr 2005
Leads Enrolled 2,095
Leads Currently Active in Study 713
Device Events 230
Cumulative Months of Follow-up 38,226
Model 3778 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 183
Lead high impedance 22
Lead fracture 12
Device stimulation issue 4
Medical device complicationa 4
Device malfunctionb 2
Not Codedc 2
Lead low impedance 1
Total Lead Events 230

a Two events were reported as lead lost capability of stimulation and 2 as open circuit on lead
b Reported as lead electrodes not functional
c Two events reported as lead malfunction

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 89.5%
(87.9%, 91.0%)
1,020
2 yrs 85.8%
(83.8%, 87.6%)
566
3 yrs 83.4%
(81.0%, 85.6%)
363
4 yrs 82.7%
(80.1%, 85.0%)
212
5 yrs 80.1%
(76.6%, 83.2%)
121
6 yrs 78.7%
(73.9%, 82.6%)
52
7 yrs 75.4%
(68.8%, 80.9%)
22
at 87 mo 75.4% 
(68.8%, 80.9%)
21

 

Model 3778 Pisces-Octad: Specifications

Device Name 1x8
Compact
ppr-3778
Lead Type Percutaneous
Lead
Length (cm) 45, 60, 75
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 4.0
Array Length (mm) 52.0

Model 3986A Resume TL: Survival from Lead Events

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

Model 3986A Resume TL: Survival from Lead Events

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Lead Characteristics
Model Number 3986A
FDA Clearance Date Apr 1995
Leads Enrolled 94
Leads Currently Active in Study 37
Device Events 14
Cumulative Months of Follow-up 2,244
Model 3986A Resume TL: Event Summary Table
Lead Event Total
Lead high impedance 8
Device stimulation issue 2
Lead low impedance 2
Lead migration/dislodgment 2
Total Lead Events 14
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 84.3%
(72.7%, 91.2%)
43
2 yrs 84.3%
(72.7%, 91.2%)
35
3 yrs 81.9%
(69.5%, 89.7%)
23
at 39 mo 81.9%
(69.5%, 89.7%)
21

 

Model 3986A Resume TL: Specifications

Device Name Resume TL ppr-3986A
Lead Type Surgical
Lead
Length (cm) 25
Diameter (mm) 1.3
Electrode
Number 4
Shape Circle
Length (mm) 4.0
Width (mm) 4.0
Individual Surface Area (mm) 12.6
Longitudinal Spacing: Edge to Edge (mm) 6.2
Lateral Spacing: Edge to Edge (mm) NA
Array Length (mm) 34.5
Array Width (mm) 4.0
Paddle
Length (mm) 44.0
Width (mm) 6.6
Thickness (mm) 1.4

Model 3998 Specify: Survival from Lead Events

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

Model 3998 Specify: Survival from Lead Events

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Lead Characteristics
Model Number 3998
FDA Approval Date Feb 1998
Leads Enrolled 142
Leads Currently Active in Study 21
Device Events 9
Cumulative Months of Follow-up 2,512
Model 3998 Specify: Event Summary Table
Lead Event Total
Lead fracture 3
Lead high impedance 3
Lead migration/dislodgment 2
Device stimulation issue 1
Total Lead Events 9
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 96.7%
(87.6%, 99.2%)
52
2 yrs 90.4%
(78.3%, 95.9%)
36
at 33 mo 87.1%  
(72.8%, 94.2%)
25

 

Model 3998 Specify: Specifications

Device Name Specify ppr-3998
Lead Type Surgical
Lead
Length (cm) 20
Diameter (mm) 1.3
Electrode
Number 8
Shape Rectangular
Length (mm) 3.0
Width (mm) 2.0
Individual Surface Area (mm) 6.0
Longitudinal Spacing: Edge to Edge (mm) 6.0
Lateral Spacing: Edge to Edge (mm) 2.0
Array Length (mm) 30.0
Array Width (mm) 6.0
Paddle
Length (mm) 45.0
Width (mm) 7.9
Thickness (mm) 1.8

Model 39565 Specify: Survival from Lead Events

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

Model 39565 Specify: Survival from Lead Events

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Lead Characteristics
Model Number 39565
FDA Approval Date Jun 2007
Leads Enrolled 178
Leads Currently Active in Study 98
Device Events 3
Cumulative Months of Follow-up 2,106
Model 39565 Specify: Event Summary Table
Lead Event Total
Lead migration/dislodgment 3
Total Lead Events 3
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 97.4%
(92.1%, 99.1%)
66
2 yrs 97.4%
(92.1%, 99.1%)
40
3 yrs 97.4%
(92.1%, 99.1%)
21

 

Model 39565 Specify: Specifications

Device Name Specify 5-6-5 ppr-39565
Lead Type Surgical
Lead
Length (cm) 30, 65
Diameter (mm) 1.3
Electrode
Number 16
Shape Rectangular
Length (mm) 4.0
Width (mm) 1.5
Individual Surface Area (mm) 6.0
Longitudinal Spacing: Edge to Edge (mm) 4.5
Lateral Spacing: Edge to Edge (mm) 1.0
Array Length (mm) 49.0
Array Width (mm) 7.5
Paddle
Length (mm) 64.2
Width (mm) 10.0
Thickness (mm) 7.5

Model 3999 2x4 Hinged: Survival from Lead Events

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

Model 3999 2x4 Hinged: Survival from Lead Events

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Lead Characteristics
Model Number 3999
FDA Approval Date Jun 2004
Leads Enrolled 52
Leads Currently Active in Study 2
Device Events 3
Cumulative Months of Follow-up 985
Model 3999 2x4 Hinged: Event Summary Table
Lead Event Total
Lead migration/dislodgment 2
Lead high impedance 1
Total Lead Events 3
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 96.5%
(77.6%, 99.5%)
32
2 yrs 93.6%
(76.7%, 98.4%)
24
at 27 mo 93.6%
(76.7%, 98.4%)
20

 

Model 3999 2x4 Hinged: Specifications

Device Name 2x4 Hinged Specify ppr-3999
Lead Type Surgical
Lead
Length (cm) 30, 45, 60
Diameter (mm) 1.3
Electrode
Number 8
Shape Rectangular
Length (mm) 3.0
Width (mm) 2.0
Individual Surface Area (mm) 6.0
Longitudinal Spacing: Edge to Edge (mm) 3.3
Lateral Spacing: Edge to Edge (mm) 3.5
Array Length (mm) 28.2
Array Width (mm) 7.5
Paddle
Length (mm) 41.0
Width (mm) 9.9
Thickness (mm) 1.8

Model 977A2 Vectris SureScan MRI 1x8 Compact: Survival from Lead Events

Lead Characteristics
Model Number 977A2
FDA Approval Date Mar 2013
Leads Enrolled 608
Leads Currently Active in Study 581
Device Events 14
Cumulative Months of Follow-up 973
Model 977A2 Vectris SureScan MRI 1x8 Compact: Event Summary Table
Lead Event Total
Lead migration/dislodgment 10
Lead high impedance 3
Lead fracture 1
Total Lead Events 14
Time Interval Survival
(95% Confidence Interval)
Sample Size
at 6 mo 93.8%
(89.5%, 96.5%)
36

 

Model 977A2 Vectris SureScan MRI 1x8 Compact: Specifications

Device Name Vectris SureScan MRI
1x8 Compact
Model 977A2 Vectris SureScan MRI
Lead Type Percutaneous
Lead
Length (cm) 60, 75, 90
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 4.0
Array Length (mm) 52.0

Lead Survival SummaryLead Survival Summary

For surgical leads, currently the estimates of device survival from lead-related events exceed 87% (confidence intervals exceed 72%) at the applicable follow-up time points that include at least 20 active devices with the exception of model 3986A.

For percutaneous leads, currently the estimates of survival from lead-related events exceed 71% (confidence intervals exceed 61%) through 5 years of follow-up for applicable leads with follow-up through that time point.  At 2 years of follow-up, model 3891 estimates of device survival are less than 76% compared to other models which exceed 84% (confidence intervals exceed 68%). As of February 6, 2008, Medtronic has discontinued worldwide distribution of the Pisces-Quad LZ lead (Models 3890, 3891, and 3892) due to performance relative to other percutaneous leads and minimal commercial demand for the product.

Lead Characteristics
Model Number Family FDA Approval Date Leads Enrolled Leads Currently Active in Study Device Eventsa Cumulative Months of Follow-up
Percutaneous Leads
3487A Pisces-Quad May 1988 880 319 133 22,440
3887 Pisces-Quad Jan 1997 164 39 15 3,765
3888 Pisces-Quad Nov 1992 383 61 24 6,608
3890 Pisces-Quad LZ Sep 2002 128 8 10 2,561
3891 Pisces-Quad LZ Sep 2002 117 6 30 1,860
3776 Pisces-Octad Nov 2005 172 49 9 2,941
3777 Pisces-Octad Apr 2005 764 188 48 13,361
3778 Pisces-Octad Apr 2005 2,095 713 230 38,226
977A2 Vectris SureScan Mar 2013 608 581 14 973
Surgical Leads
3986A Resume TL Apr 1995b 94 37 14 2,244
3998 Specify Feb 1998 142 21 9 2,512
3999 2 x 4 Hinged Specify Jun 2004 52 2 3 985
39565 Specify Jun 2007 178 98 3 2,446

a There were a total of 640 lead-related events reported to the registry, but only 542 events included in this summary table. The remaining lead-related events occurred in lead models for which no device survival curves are presented due to an insufficient number of enrolled devices (n=4), a lead with an unknown model number (n=1), or were subsequent or unlinked device events that did not affect the survival estimates.
b FDA clearance date

Device Survival Probability (95% Confidence Interval)Table 1 of 3
Model
Number
Family 1 yr 2 yrs 3 yrs 4 yrs
Percutaneous Leads
3487A Pisces-Quad 90.5%
(87.5%, 92.8%)
87.6%
(84.2%, 90.3%)
81.8%
(77.7%, 85.2%)
74.9%
(70.0%, 79.1%)
3887 Pisces-Quad 95.6%
(72.4%, 99.4%)
84.4%
(68.9%, 92.6%)
80.6%
(65.2%, 89.7%)
78.9%
(63.5%, 88.3%)
3888 Pisces-Quad 92.0%
(87.0%, 95.1%)
90.2%
(84.6%, 93.9%)
84.1%
(75.3%, 90.0%)
82.6%
(73.3%, 88.9%)
3890 Pisces-Quad LZ 100.0%
NA
97.7%
(84.8%, 99.7%)
89.0%
(75.6%, 95.3%)
89.0%
(75.6%, 95.3%)
3891 Pisces-Quad LZ 78.9%
(67.5%, 86.8%)
75.5%
(63.4%, 84.1%)
- -
3776 Pisces-Octad 93.4%
(87.2%, 96.6%)
93.4%
(87.2%, 96.6%)
93.4%
(87.2%, 96.6%)
90.2%
(79.5%, 95.5%)
3777 Pisces-Octad 92.5%
(89.5%, 94.6%)
88.5%
(84.8%, 91.4%)
88.5%
(84.8%, 91.4%)
88.5%
(84.8%, 91.4%)
3778 Pisces-Octad 89.5%
(87.9%, 91.0%)
85.8%
(83.8%, 87.6%)
83.4%
(81.0%, 85.0%)
82.7%
(80.1%, 85.0%)
977A2 Vectris SureScan a - - -
Surgical Leads
3986A Resume TL 84.3%
(72.7%, 91.2%)
84.3%
(72.7%, 91.2%)
81.9%
(69.5%, 89.7%)
-
3998 Specify 96.7%
(87.6%, 99.2%)
90.4%
(78.3%, 95.9%)
- -
3999 2 x 4 Hinged Specify 96.5%
(77.6%, 99.5%)
93.6%
(76.7%, 98.4%)
- -
39565 Specify 97.4%
(92.1%, 99.1%)
97.4%
(92.1%, 99.1%)
97.4%
(92.1%, 99.1%)
-

a Model 977A2 had a device survival probability of 93.9% (89.5% , 96.5%) at 6 months of follow-up

Device Survival Probability (95% Confidence Interval)Table 2 of 3
Model
Number
Family 5 yrs 6 yrs 7 yrs 8 yrs
Percutaneous Leads
3487A Pisces-Quad 71.5%
(66.2%, 76.1%)
68.5%
(62.7%, 73.5%)
66.2%
(60.1%, 71.7%)
66.2%
(60.1%, 71.7%)
3887 Pisces-Quad 76.7%
(66.2%, 76.1%)
73.9%
(57.9%, 84.6%)
- -
3888 Pisces-Quad 79.2%
(68.9%, 86.4%)
79.2%
(68.9%, 86.4%)
79.2%
(68.9%, 86.4%)
79.2%
(68.9%, 86.4%)
3890 Pisces-Quad LZ 82.7%
(66.5%, 91.5%)
- - -
3891 Pisces-Quad LZ - - - -
3776 Pisces-Octad - - - -
3777 Pisces-Octad 87.2%
(82.4%, 90.7%)
83.5%
(75.9%, 88.9%)
83.5%
(75.9%, 88.9%)
-
3778 Pisces-Octad 80.1%
(76.6%, 83.2%)
78.7%
(73.9%, 82.6%)
75.4%
(68.8%, 80.9%)
-
977A2 Vectris SureScan - - - -
Surgical Leads
3986A Resume TL - - - -
3998 Specify - - - -
3999 2 x 4 Hinged Specify - - - -
39565 Specify - - - -

 

Device Survival Probability (95% Confidence Interval)Table 3 of 3
Model
Number
Family 9 yrs 10 yrs 11 yrs
Percutaneous Leads
3487A Pisces-Quad 66.2%
(60.1%, 71.7%)
62.9%
(55.4%, 69.6%)
60.9%
(52.4%, 68.3%)
3887 Pisces-Quad - - -
3888 Pisces-Quad - - -
3890 Pisces-Quad LZ - - -
3891 Pisces-Quad LZ - - -
3776 Pisces-Octad - - -
3777 Pisces-Octad - - -
3778 Pisces-Octad - - -
977A2 Vectris SureScan - - -
Surgical Leads
3986A Resume TL - - -
3998 Specify - - -
3999 2 x 4 Hinged Specify - - -
39565 Specify - - -

Extensions

From June 2004 to the report cut-off date of July 31, 2014, there were 2,898 extensions followed in the registry.  Differences between the total number of extensions versus spinal cord stimulators (N=3,521) was due to the fact that some systems did not use an extension. The aggregate prospective follow-up time for all extensions was 60,684 months (5,057 years).

An extension is a set of thin wires with a protective coating that connects the neurostimulator to the lead. The table below provides the number and percentage of extensions by model.

Extensions by Mode
Model Number Number of Extensions (%)
37081 1,155 (39.9%)
7489 707 (24.4%)
37082 573 (19.8%)
7495 229 (7.9%)
37083 198 (6.8%)
7472 12 (0.4%)
7496 9 (0.3%)
7471 8 (0.3%)
Other/Unspecified 7 (0.2%)
Total 2,898 (100%)

Extension EventsExtension Events

There were 22 product performance-related events with an underlying reported etiology related to the extension. Of these events, the majority were extension fractures (n=13). Of the 22 events, 15 were the first event attributable to an enrolled extension.

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 extensions:

  • 15 had follow-up time cut-off due to product performance-related events.  
  • 1,790 were censored in the survival analysis for the following reasons: patient expired, extension explanted, site termination, patient discontinued, other extension modification, therapy suspended, or non-product performance extension-related event without an associated intervention.
  • 1,093 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Extension Survival Extension Survival

The figures and tables below represent extension survival and 95% confidence intervals where at least 20 extensions contributed to each 3-month interval.  Currently, estimates of device survival from extension-related events exceed 95% (confidence intervals exceed 89%) for all extension models at the applicable follow-up time points that include at least 20 active devices.

              
   

Model 7489: Survival from Extension Events

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

Model 7489: Survival from Extension Events

View Larger Image

Extension Characteristics
Model Number 7489
FDA Approval Date Oct 2002
Extensions Enrolled 707
Extensions Currently Active in Study 71
Device Events 3
Cumulative Months of Follow-up 15,379
Model 7489 Extension: Event Summary Table
Extension Event Total
Extension fracture 2
Medical device complicationa 1
Total Extension Events 4

a Reported as unknown problem with extension

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.6% 
(97.2%, 99.9%)
285
2 yrs 99.6% 
(97.2%, 99.9%)
274
3 yrs 98.8% 
(96.2%, 99.6%)
193
4 yrs 98.8% 
(96.2%, 99.6%)
130
5 yrs 98.8% 
(96.2%, 99.6%)
97
6 yrs 98.8% 
(96.2%, 99.6%)
69
7 yrs 98.8% 
(96.2%, 99.6%)
57
8 yrs 98.8% 
(96.2%, 99.6%)
53
9 yrs 98.8% 
(96.2%, 99.6%)
35
at 117 mo 98.8% 
(96.2%, 99.6%)
23

 

Model 7489: Specifications

Device Name Low Profile Quad Extension Model 7489: Low Profile Quad Extension
Length (cm) 10, 25, 40, 51, 66
Distal End Compatibility 1 Quad Lead
Distal End Set Screws 4
Proximal End INS Compatibility Itrel 3, Synergy, Versitrel

Model 37081: Survival from Extension Events

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

Model 37081: Survival from Extension Events

View Larger Image

Extension Characteristics
Model Number 37081
FDA Approval Date Apr 2005
Extensions Enrolled 1,155
Extensions Currently Active in Study 395
Device Events 5
Cumulative Months of Follow-up 20,541
Model 37081 Extension: Event Summary Table
Extension Event Total
Extension fracture 5
Total Extension Events 5
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.9%
(99.1%, 100.0%)
562
2 yrs 99.4%
(98.0%, 99.8%)
309
3 yrs 98.6%
(96.6%, 99.5%)
177
4 yrs 98.6%
(96.6%, 99.5%)
104
5 yrs 98.6%
(96.6%, 99.5%)
64
6 yrs 98.6%
(96.6%, 99.5%)
32
at 81 mo 98.6%
(96.6%, 99.5%)
22

 

Model 37081: Specifications

Device Name 1x8 Extension Model 37081: 1x8 Extension
Length (cm) 20, 40, 60
Distal End Compatibility 1 Octad Lead
Distal End Set Screws 1
Proximal End INS Compatibility Restore Family

Model 37082: Survival from Extension Events

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

Model 37082: Survival from Extension Events

View Larger Image

Extension Characteristics
Model Number 37082
FDA Approval Date Mar 2006
Extensions Enrolled 573
Extensions Currently Active in Study 182
Device Events 3
Cumulative Months of Follow-up 13,786
Model 37082 Extension: Event Summary Table
Extension Event Total
Extension fracture 2
Paraesthesiaa 1
Total Extension Events 3

a Physician reported shocking sensation at battery/extension connection

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.5%
(98.2%, 99.9%)
341
2 yrs 99.2%
(97.6%, 99.8%)
219
3 yrs 99.2%
(97.6%, 99.8%)
132
4 yrs 99.2%
(97.6%, 99.8%)
100
5 yrs 99.2%
(97.6%, 99.8%)
64
6 yrs 99.2%
(97.6%, 99.8%)
40
at 75 mo 99.2%
(97.6%, 99.8%)
20

 

Model 37082: Specifications

Device Name Bifurcated Stretch-Coil Extension Model 37082: Bifurcated Stretch-Coil Extension
Length (cm) 20, 40, 60
Distal End Compatibility 2 Quad Leads
Distal End Set Screws 8 (4 per Lead)
Proximal End INS Compatibility Restore Family

Model 37083: Survival from Extension Events

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

Model 37083: Survival from Extension Events

View Larger Image

Extension Characteristics
Model Number 37083
FDA Approval Date Sep 2005
Extensions Enrolled 198
Extensions Currently Active in Study 37
Device Events 4
Cumulative Months of Follow-up 4,798
Model 37083 Extension: Event Summary Table
Extension Event Total
Extension fracture 3
Device failurea 1
Total Extension Events 4

a Reported as extension failure

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.1%
(93.5%, 99.9%)
118
2 yrs 97.2%
(91.6%, 99.1%)
92
3 yrs 95.9%
(89.3%, 98.5%)
55
4 yrs 95.9%
(89.3%, 98.5%)
43
5 yrs 95.9%
(89.3%, 98.5%)
24
at 66 mo 95.9%
(89.3%, 98.5%)
21

 

Model 37083: Specifications

Device Name Single Stretch-Coil Extension Model 37083: Single Stretch-Coil Extension
Length (cm) 20, 40, 60
Distal End Compatibility 1 Quad Lead
Distal End Set Screws 4
Proximal End INS Compatibility Restore Family

Extension Survival SummaryExtension Survival Summary

Currently, estimates of device survival from extension-related events exceed 95% (confidence intervals exceed 89%) for all extension models at the applicable follow-up time points that include at least 20 active devices.

Extension Characteristics
Model Number Family FDA Approval Date Extensions Enrolled Extensions Currently Active in Study Device Eventsa Cumulative Months of Follow-up
37081 37081 Apr
2005
1,155 395 5 20,541
37082 37082 Mar
2006
573 182 3 13,786
37083 37083 Sep
2005
198 37 4 4,798
7489 7489 Oct
2002
707 71 3 15,379

a There were a total of 22 extension-related events reported to the registry, but only 15 events are included in this summary table. The remaining 7 events were unlinked device events that did not affect the survival estimates.

Device Survival Probability (95% Confidence Interval)Table 1 of 2
Model Number 1 yr 2 yrs 3 yrs 4 yrs 5 yrs
37081 99.9%
(99.1%, 100.0%)
99.4%
(98.0%, 99.8%)
98.6%
(96.6%, 99.5%)
98.6%
(96.6%, 99.5%)
98.6%
(96.6%, 99.5%)
37082 99.5%
(98.2%, 99.9%)
99.2%
(97.6%, 99.8%)
99.2%
(97.6%, 99.8%)
99.2%
(97.6%, 99.8%)
99.2%
(97.6%, 99.8%)
37083 99.1%
(93.5%, 99.9%)
97.2%
(91.6%, 99.1%)
95.9%
(89.3%, 98.5%)
95.9%
(89.3%, 98.5%)
95.9%
(89.3%, 98.5%)
7489 99.6%
(97.2%, 99.9%)
99.6%
(97.2%, 99.9%)
98.8%
(96.2%, 99.6%)
98.8%
(96.2%, 99.6%)
98.8%
(96.2%, 99.6%)

 

Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Number 6 yrs 7 yrs 8 yrs 9 yrs
37081 98.6%
(96.6%,
99.5%)
- - -
37082 99.2%
(97.6%,
99.8%)
99.2%
(97.6%,
99.8%)
- -
37083

- - - -
7489 98.8%
(96.2%,
99.6%)
98.8%
(96.2%,
99.6%)
98.8%
(96.2%,
99.6%)
98.8%
(96.2%,
99.6%)

2014 Medtronic Product Performance Report: Data through July 31, 2014

United States