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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, 2016. Seventy-five centers enrolled and contributed patients.


Patients

Of the 4,286 total spinal cord stimulation patients enrolled, 44.6% were implanted for the treatment of “other” pain indications, 43.5% were implanted for the treatment of failed back pain, 11.0% were implanted for the treatment of complex regional pain syndrome (CRPS), and 0.9% 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 1,912 (44.6%)
Other chronic pain 765 (17.8%)
Radicular pain syndrome 597 (13.9%)
Other 261 (6.1%)
Degenerative disc disease 168 (3.9%)
Cervical pain 35 (0.8%)
Traumatic nerve injury 31 (0.7%)
Diabetic neuropathy 25 (0.6%)
Post herpetic neuralgia 11 (0.3%)
Facial pain 6 (0.1%)
Angina 4 (0.1%)
Epidural fibrosis 4 (0.1%)
Post herniorrhaphy pain 3 (0.1%)
Chronic cluster headache 2 (<0.1%)
Failed Back Pain 1,863 (43.5%)
Postlaminectomy pain 750 (17.5%)
Failed Back Syndrome (FBS) 625 (14.6%)
Combination back and leg pain 376 (8.8%)
Multiple back operations 83 (1.9%)
Arachnoiditis 21 (0.5%)
Unsuccessful disc surgery 8 (0.2%)
CRPS 472 (11.0%)
CRPS I 361 (8.4%)
CRPS II 111 (2.6%)
Not Specified 39 (0.9%)
Total Patients 4,286

a Refer to product labeling for approved indications.

Event Summary

There were 2,755 events reported between June 2004 and July 31, 2016 in patients with spinal cord stimulation systems. Over thirty-seven percent of these events (1,034/2,755) were categorized as product performance-related and are presented within this report. The 1,034 product performance events occurred in 490 of the 4,286 total patients (11.4%) enrolled. In addition, there were 1,721 non-product performance events. There were also 123 deaths reported for patients with spinal cord stimulation systems, none of which 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.

Spinal Cord Stimulation System Product Performance Events
Eventa Number of Product
Performance
Events
Number of Patients with Eventb Percent of Patients with Event
(n=4,286)
Lead migration/dislodgement 505 264 6.2%
High impedance 226 107 2.5%
Lead fracture 64 41 1.0%
Device stimulation issuec 47 26 0.6%
Low impedance 37 13 0.3%
Neurostimulator unable to recharged 34 32 0.8%
Device malfunctione 24 22 0.5%
Medical device complicationf 17 12 0.3%
Extension fracture 15 10 0.2%
Device breakageg 13 13 0.3%
Device lead damage 7 5 0.1%
Device connection issue 5 3 0.1%
Extension migration 5 3 0.1%
Device failureh 4 3 0.1%
Device telemetry issue 4 4 0.1%
Impedance increased 4 3 0.1%
Battery recharge issued 3 3 0.1%
Device battery issue 3 3 0.1%
Device issue 3 3 0.1%
Device component issuei 2 2 0.1%
Inadequate lead connection 2 1 <0.1%
Paraesthesiaj 2 2 0.1%
Therapeutic product ineffective 2 1 <0.1%
Antenna cable breakage 1 1 <0.1%
Broken bond wire 1 1 <0.1%
Device electrical impedance issue 1 1 <0.1%
Device kink 1 1 <0.1%
Device lead issue 1 1 <0.1%
Not Codedk 1 1 <0.1%
Totals 1,034 490 11.4%

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 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=45).
d There were a total of 2,671 patients that used rechargeable SCS neurostimulators in the registry. A total of 1.3% (35/2,671) of patients with a rechargeable SCS neurostimulator experienced a neurostimulator unable to recharge or battery recharge issue product performance event.
e Includes 5 charger malfunctions, 4 patient programmer malfunctions, 3 antenna malfunctions, 2 neurostimulator malfunctions, 2 events for impedance not measurable, 2 events for non-functional lead electrodes, 1 event for lead impedance changes, 1 event for error message on programmer, 1 inability to turn neurostimulator on, 1 suspected device malfunction, 1 recharging cable malfunction, and 1 event for neurostimulator stopped working abruptly.
f Includes 4 leads no longer providing stimulation, 4 error messages on patient programmer, 2 events reported as unable to pass stylet into lead, 2 leads with open circuits, 1 loose anchor, 1 hybrid anomaly, 1 unknown problem with extension, 1 defective patient programmer, 1 excessive heating of charging unit.
g Includes 6 broken charger belts, 1 broken antenna, 1 broken antenna and jack, 1 broken charger, 1 broken patient programmer, 1 frayed cord to charger antenna, 1 broken charger cord, and 1 frayed wire to charger.
h Includes 2 events for lead failure, 1 event for failure of lead electrodes, and 1 extension failure.
i Includes 1 event for damaged antenna cord, and 1 faulty antenna.
j Includes 1 event for shocking sensation at battery site and 1 shocking sensation at battery/extension connection.
k Event that had not been MedDRA-coded at the time of the report cut-off.

A total of 862 (83.4%) of the 1,034 product performance events were related to the lead, 46 (4.4%) were related to “other device”, 38 (3.7%) were related to “multiple etiologies”, which includes events where at least one device and one non-device etiology was indicated, 29 (2.8%) were related to the neurostimulator, 27 (2.6%) were related to the extension, 19 (1.8%) were related to the recharging process, 6 (0.6%) were related to programming/stimulation, 3 (0.3%) were related to “other” etiology, 2 (0.2%) were related to the incisional site/device tract, and 2 (0.2%) were related to surgery/anesthesia. Relatedness is determined by the physician.

Product Performance Events by Relatednessa 

Product Performance Events by Relatedness

aEach event could have more than one etiology.

 
Spinal Cord Stimulation 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 550
   Device stimulation issuec 295
   Battery recharge issued 64
   Neurostimulator unable to rechargee 64
   Device battery issuef 27
   Neurostimulator migration 27
   Neurostimulator inversion 19
   Device use error 13
   Device difficult to use 8
   Device malfunctiong 7
   Device extrusion 5
   Otherh 21
Therapeutic and nontherapeutic effects (excluding toxicity) 394
   Therapeutic product ineffective 182
   Therapeutic response decreased 149
   No therapeutic response 58
   Otherh 5
Administration site reactions 249
   Implant site pain 172
   Implant site erythema 18
   Implant site extravasation 17
   Implant site erosion 13
   Otherh 29
Infections - pathogen unspecified 137
   Implant site infection 74
   Device related infection 22
   Infection 18
   Wound infection 11
   Incision site infection 7
   Otherh 5
General system disorders Not Elsewhere Classified (NEC) 116
   Pain 87
   No anomaly found by RPAi 19
   Otherh 10
Procedural related injuries and complications NEC 63
   Incision site erythema 12
   Incision site pain 10
   Wound dehiscence 10
   Seroma 6
   Suture related complication 5
   Otherh 20
Neurological disorders NEC 45
   Paraesthesia 27
   Otherh 18
Musculoskeletal and connective tissue disorders NEC 44
   Pain in extremity 21
   Back pain 17
   Otherh 6
Complications associated with device 23
   Medical device discomfort 18
   Otherh 5
Spinal cord and nerve root disorders 15
   Radiculopathy 14
   Otherh 1
Headaches 10
   Headache 9
   Otherh 1
Muscle disorders 9
   Muscle spasms 6
   Otherh 3
Tissue disorders NEC 8
   Impaired healing 8
Otherh 58
Total 1,721

a Adverse events associated with product performance events are not included in this table. Related adverse and device events reported on a single event form are represented individually 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 either not device related or had no associated device event.
d Events reported as recharge issues not due to a device malfunction.
e Patients with these events were unable to recharge due to an issue not related to the device.
f Events reported as battery discharge or depletion not due to a device malfunction.
g Events were device issues due to patient use or other non-device defect etiology.
h Composed of event codes with fewer than 5 events each.
i 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 123 deaths reported for patients with spinal cord stimulation systems. None of these deaths were reported as a direct result of a product performance event. As indicated, 62 (50.4%) of the deaths occurred in patients receiving therapy for pain indications in the "other" category, 51 (41.5%) for failed back, and 10 (8.1%) for CRPS.

Death by Primary Indication
Primary Indicationa N (%)
Other 62 (50.4%)
Failed Back 51 (41.5%)
CRPS 10 (8.1%)
Total 123 (100%)

a Refer to product labeling for approved indications

Spinal Cord Neurostimulators

From June 2004 to the report cut-off date of July 31, 2016, 4,731 spinal cord neurostimulators were followed in the registry. The difference between the total number of patients (N=4,286) versus neurostimulators is due to the fact that some patients had multiple neurostimulators or were subsequently re-implanted. The aggregate prospective follow-up time for all spinal cord neurostimulators was 81,755 months (6,813 years). The table below provides the number and percentage of spinal cord neurostimulators by model.

Spinal Cord Neurostimulators by Model
Model Number of Neurostimulators (%)
RestoreSensor SureScan MRI (97714) 936 (19.8%)
PrimeAdvanced (37702) 671 (14.2%)
RestoreSensor (37714) 376 (7.9%)
RestoreAdvanced (37713) 357 (7.5%)
PrimeAdvanced SureScan MRI (97702) 421 (8.9%)
RestoreAdvanced SureScan MRI (97713) 99 (2.1%)
Itrel 4 (37703) 74 (1.6%)
RestoreUltra SureScan MRI (97712) 57 (1.2%)
Other/Unspecified 19 (0.4%)
Neurostimulators No Longer Manufactured
RestoreUltra (37712) 581 (12.3%)
Synergy (7427) 461 (9.7%)
Restore (37711) 448 (9.5%)
Itrel 3 (7425) 97 (2.1%)
RestorePrime (37701) 57 (1.2%)
Synergy Versitrel (7427V) 53 (1.1%)
Synergy Plus (7479) 16 (0.3%)
Synergy Compact (7479B) 8 (0.2%)
Total 4,731 (100%)

Neurostimulator Events Neurostimulator Events

There were 37 product performance-related events with an underlying reported etiology related to spinal cord neurostimulator function. This includes 29 events with a neurostimulator etiology and 8 events with both a neurostimulator and other etiology (including device and non-device etiologies). Of these, 31 were the initial product performance event that affected neurostimulator survival estimates. For spinal cord neurostimulators in the registry, the current return rate to Medtronic Returned Product Analysis (RPA) was 274/1,118 (25%). The proportion was based upon the number of registry spinal cord neurostimulators received by RPA, divided by the total number of explanted devices plus the total number of neurostimulators in patients who have expired. One of the 37 spinal cord neurostimulator events was confirmed by Medtronic RPA as a broken bond wire. The neurostimulators with the remaining 36 performance-related events were not returned to Medtronic RPA and the events were assigned as device related by the physician. These events included: neurostimulator unable to recharge (n=9), high impedance (n=5), device battery issue (n=3), device malfunction (n=3), lead migration/dislodgement (n=3), medical device complication (n=3), battery recharge issue (n=2), device issue (n=2), device stimulation issue (n=2), device connection issue (n=1), device telemetry issue (n=1), extension migration (n=1), and low impedance (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 neurostimulators:

  • 31 had follow-up time cut-off due to product performance-related events.
  • 3,092 were censored in the survival analysis for the following reasons: patient expired, neurostimulator explanted, site termination, patient discontinued, other neurostimulator modification, therapy suspended, or non-product performance neurostimulator-related event without an associated intervention.
  • 1,608 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Neurostimulator SurvivalNeurostimulator Survival

The figures and tables below represent spinal cord neurostimulator survival and 95% confidence intervals where at least 20 spinal cord neurostimulators contributed to each 3-month interval.

                                                                             

Model 7425 Itrel 3: Survival from Spinal Cord Neurostimulator Events

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

Model 7425 Itrel 3: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name Itrel 3
FDA Approval Date Aug 1995
Neurostimulators Enrolled 97
Neurostimulators Currently Active in Study 1
Device Events 0
Cumulative Months of Follow-up 1,425
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0%
(NA)
35
2 yrs 100.0%
(NA)
26
at 30 mo 100.0%
(NA)
22

 

Model 7425 Itrel 3: Specifications

Height 2.2 in (55 mm) ppr-8627-18
Width 2.4 in (60 mm)
Thickness 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 37703 Itrel 4: Survival from Spinal Cord Neurostimulator Events

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

Model 37703 Itrel 4: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name Itrel 4
FDA Approval Date May 2012
Neurostimulators Enrolled 74
Neurostimulators Currently Active in Study 64
Device Events 0
Cumulative Months of Follow-up 795
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 37
at 18 mo 100.0% (NA) 21

Model 37703 Itrel 4: Specifications

Height 2.2 in (55 mm) ppr-itrel4
Width 2.4 in (60 mm)
Thickness 0.4 in (11 mm)
Volume 28 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 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 1
Programs 1
Implant Depth ≤ 4 cm

 

Model 7427 Synergy: Survival from Spinal Cord Neurostimulator 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 Neurostimulator Characteristics
Model Name Synergy
FDA Approval Date Nov 1999
Neurostimulators Enrolled 461
Neurostimulators Currently Active in Study 9
Device Events 3
Cumulative Months of Follow-up 9,396
Model 7427 Synergy: Event Summary Table
Neurostimulator Event Total
Broken bond wire 1
Device stimulation issue 1
Device connection issue 1
Total Neurostimulator Events 3
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0%
(NA)
208
2 yrs 99.5%
(96.6%, 99.9%)
176
3 yrs 99.5%
(96.6%, 99.9%)
119
4 yrs 98.6%
(94.4%, 99.7%)
79
5 yrs 97.3%
(91.4%, 99.2%)
44
6 yrs 97.3%
(91.4%, 99.2%)
32
7 yrs 97.3%
(91.4%, 99.2%)
21
at 87 mo 97.3%
(91.4%, 99.2%)
20

 

Model 7427 Synergy: Specifications

Height 2.4 in (61 mm) ppr-7427
Width 3.0 in (76 mm)
Thickness 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 Neurostimulator 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 Neurostimulator Characteristics
Model Name RestorePrime
FDA Approval Date Mar 2006
Neurostimulators Enrolled 57
Neurostimulators Currently Active in Study 1
Device Events 0
Cumulative Months of Follow-up 1,249
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0%
(NA)
38
2 yrs 100.0%
(NA)
23
at 27 mo 100.0%
(NA)
21

 

Model 37701 RestorePrime: Specifications

Height 2.6 in (65 mm) ppr-37701
Width 1.9 in (49 mm)
Thickness 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 Neurostimulator Events

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

Model 37702 PrimeAdvanced: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name PrimeAdvanced
FDA Approval Date Jul 2006
Neurostimulators Enrolled 671
Neurostimulators Currently Active in Study 103
Device Events 4
Cumulative Months of Follow-up 12,149
Model 37702 PrimeAdvanced: Event Summary Table
Neurostimulator Event Total
Device battery issue 1
Device stimulation issue 1
High impedance 1
Low impedance 1
Total Neurostimulator Events 4
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.8%
(98.5%,100.0%)
366
2 yrs 99.5%
(97.9%,99.9%)
201
3 yrs 98.9%
(96.1%,99.7%)
95
4 yrs 98.9%
(96.1%,99.7%)
47
5 yrs 98.9%
(96.1%,99.7%)
22

 

Model 37702 PrimeAdvanced: Specifications

Height 2.6 in (65 mm) ppr-37702
Width 1.9 in (49 mm)
Thickness 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 Neurostimulator Events

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

Model 37711 Restore: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name Restore
FDA Approval Date Apr 2005
Neurostimulators Enrolled 448
Neurostimulators Currently Active in Study 13
Device Events 4
Cumulative Months of Follow-up 12,959
Model 37711 Restore: Event Summary Table
Neurostimulator Event Total
Neurostimulator unable to recharge 2
Battery recharge issue 1
Device malfunctiona 1
Total Neurostimulator Events 4

aReported as suspected device malfunction.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0%
(NA)
278
2 yrs 100.0%
(NA)
221
3 yrs 100.0%
(NA)
144
4 yrs 100.0%
(NA)
91
5 yrs 100.0%
(NA)
71
6 yrs 98.3%
(88.5%, 99.8%)
53
7 yrs 98.3%
(88.5%, 99.8%)
41
8 yrs 98.3%
(88.5%, 99.8%)
29
at 102 mo 91.6%
(75.3%, 97.3%)
24

 

Model 37711 Restore: Specifications

Height 2.6 in (65 mm) ppr-37711
Width 1.9 in (49 mm)
Thickness 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 Neurostimulator Events

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

Model 37712 RestoreUltra: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name RestoreUltra
FDA Approval Date Jan 2008
Neurostimulators Enrolled 581
Neurostimulators Currently Active in Study 65
Device Events 7
Cumulative Months of Follow-up 13,240
Model 37712 RestoreUltra: Event Summary Table
Neurostimulator Event Total
Neurostimulator unable to recharge 3
Device battery issue 1
Device issue 1
Device malfunctiona 1
Medical device complicationb 1
Total Neurostimulator Events 7

a Reported as malfunction of the spinal cord stimulation system.
bReported as error message on patient programmer.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100%
(NA)
334
2 yrs 99.6%
(97.2%, 99.9%)
195
3 yrs 99.1%
(96.3%, 99.8%)
130
4 yrs 98.1%
(93.6%, 99.4%)
88
5 yrs 96.4%
(89.4%, 98.8%)
58
6 yrs 94.4%
(85.3%, 97.9%)
31
at 81 mo 91.0%
(77.6%, 96.5%)
21

 

Model 37712 RestoreUltra: Specifications

Height 2.1 in (54 mm) ppr-37712
Width 2.1 in (54 mm)
Thickness 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 37713 RestoreAdvanced: Survival from Spinal Cord Neurostimulator Events

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

Model 37713 RestoreAdvanced: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name RestoreAdvanced
FDA Approval Date Jul 2006
Neurostimulators Enrolled 357
Neurostimulators Currently Active in Study 53
Device Events 1
Cumulative Months of Follow-up 9,479
Model 37713 RestoreAdvanced: Event Summary Table
Neurostimulator Event Total
Medical device complicationa 1
Total Neurostimulator Events 1

a Reported as simulation therapy did not meet patient's expectations.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.6%
(97.5%, 99.9%)
224
2 yrs 99.6%
(97.5%, 99.9%)
155
3 yrs 99.6%
(97.5%, 99.9%)
95
4 yrs 99.6%
(97.5%, 99.9%)
60
5 yrs 99.6%
(97.5%, 99.9%)
44
6 yrs 99.6%
(97.5%, 99.9%)
32
7 yrs 99.6%
(97.5%, 99.9%)
21

 

Model 37713 RestoreAdvanced: Specifications

Height 2.6 in (65 mm) ppr-37713
Width 1.9 in (49 mm)
Thickness 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 37714 RestoreSensor: Survival from Spinal Cord Neurostimulator Events

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

Model 37714 RestoreSensor: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name RestoreSensor
FDA Approval Date Nov 2011
Neurostimulators Enrolled 376
Neurostimulators Currently Active in Study 197
Device Events 2
Cumulative Months of Follow-up 6,437
Model 37714 RestoreSensor: Event Summary Table
Neurostimulator Event Total
Battery recharge issue 1
Neurostimulator unable to recharge 1
Total Neurostimulator Events 2
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.6%
(97.4%, 99.9%)
216
2 yrs 99.1%
(96.1%, 99.8%)
119
3 yrs 99.1%
(96.1%, 99.8%)
40
at 39 mo 99.1%
(96.1%, 99.8%)
23

 

Model 37714 RestoreSensor: Specifications

Height 2.1 in (54 mm) ppr-37714
Width 2.1 in (54 mm)
Thickness 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

Model 97702 PrimeAdvanced SureScan MRI: Survival from Spinal Cord Neurostimulator Events

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

Model 97702 PrimeAdvanced SureScan MRI: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name PrimeAdvanced SureScan MRI
FDA Approval Date Mar 2013
Neurostimulators Enrolled 421
Neurostimulators Currently Active in Study 326
Device Events 1
Cumulative Months of Follow-up 3,625
Model 97702 PrimeAdvanced SureScan MRI: Event Summary Table
Neurostimulator Event Total
Device battery issue 1
Total Neurostimulator Events 1
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.6%
(97.0%, 99.9%)
132
2 yrs 99.6%
(97.0%, 99.9%)
29

Model 97702 PrimeAdvanced SureScan MRI: Specifications

Height 2.6 in (65 mm) ppr-97702
Width 1.9 in (49 mm)
Thickness 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 3 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 32
Implant Depth ≤ 4 cm

 

Model 97712 RestoreUltra SureScan MRI: Survival from Spinal Cord Neurostimulator Events

Spinal Cord Neurostimulator Characteristics
Model Name RestoreUltra SureScan MRI
FDA Approval Date Mar 2013
Neurostimulators Enrolled 57
Neurostimulators Currently Active in Study 43
Device Events 0
Cumulative Months of Follow-up 405
Time Interval Survival
(95% Confidence Interval)
Sample Size
at 6 mo 100%
(NA)
26

Model 97712 RESTOREULTRA SURESCAN MRI: Specifications

Height 2.1 in (54 mm) ppr-97712
Width 2.1 in (54 mm)
Thickness 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 97713 RestoreAdvanced SureScan MRI: Survival from Spinal Cord Neurostimulator Events

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

Model 97713 RestoreAdvanced SureScan MRI: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name RestoreAdvanced SureScan MRI
FDA Approval Date Mar 2013
Neurostimulators Enrolled 99
Neurostimulators Currently Active in Study 76
Device Events 1
Cumulative Months of Follow-up 869
Model 97713 RestoreAdvanced SureScan MRI: Event Summary Table
Neurostimulator Event Total
Device malfunctiona 1
Total Neurostimulator Events 1

aReported as malfunction of spinal cord neurostimulator.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 98.2%
(88.1%, 99.7%)
33
at 18 mo 98.2%
(88.1%, 99.7%)
20

Model 97713 RestoreAdvanced Surescan MRI: Specifications

Height 2.6 in (65 mm) ppr-97713
Width 1.9 in (49 mm)
Thickness 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 97714 RestoreSensor SureScan MRI: Survival from Spinal Cord Neurostimulator Events

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

Model 97714 RestoreSensor SureScan MRI: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name RestoreSensor SureScan MRI
FDA Approval Date Mar 2013
Neurostimulators Enrolled 936
Neurostimulators Currently Active in Study 720
Device Events 6
Cumulative Months of Follow-up 8,127
Model 97714 RestoreSensor SureScan MRI: Event Summary Table
Neurostimulator Event Total
Lead migration/dislodgement 3
Device telemetry issue 1
High impedance 1
Neurostimulator unable to recharge 1
Total Neurostimulator Events 6
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.2%
(98.0%, 99.7%)
297
2 yrs 99.2%
(98.0%, 99.7%)
54
at 27 mo 99.2%
(98.0%, 99.7%)
26

 

Model 97714 RestoreSensor SureScan MRI: Specifications

Height 54 mm (2.1 in) ppr-97714
Width 54 mm (2.1 in)
Thickness 9 mm (0.4 in)
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 msec
Groups 8
Programs 16
Implant Depth ≤ 1 cm

Spinal Cord Stimulator Survival Summary Spinal Cord Stimulator Survival Summary

Spinal Cord Neurostimulator Survival Summary Table
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
97 1 0 1,425
Itrel 4 Itrel 4 May
2012
74 64 0 795
Synergy Synergy Nov
1999
461 9 3 9,396
Restore
Prime
Restore Mar
2006
57 1 0 1,249
Prime
Advanced
Prime
Advanced
Jul
2006
671 103 4 12,149
Prime
Advanced
SureScan
MRI
Prime
Advanced
Mar
2013
421 326 1 3,625
Rechargeable Neurostimulators
Restore Restore Apr
2005
448 13 4 12,959
Restore
Ultra
Restore Jan
2008
581 65 7 13,240
Restore
Advanced
Restore Jul
2006
357 53 1 9,479
Restore
Sensor
Restore Nov
2011
376 197 2 6,437
Restore
Ultra
SureScan
MRI
Restore Mar
2013
57 43 0 405
Restore
Advanced
SureScan
MRI
Restore Mar
2013
99 76 1 869
Restore
Sensor
SureScan
MRI
Restore Mar
2013
936 720 6 8,127

a There were 37 neurostimulator-related events reported to the registry, but only 29 events included in this summary table. The remaining neurostimulator related events occurred in a model for which no device survival data are presented due to an insufficient number of enrolled devices (n=2), or were subsequent events (i.e. additional events that occurred after the survival censoring event) that did not affect the device survival estimates.
bRestoreUltra SureScan MRI had a device survival probability of 100% at 6 months of follow-up.

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)
- -
Itrel 4 100.0%
(NA)
- - -
Synergy 100.0%
(NA)
99.5%
(96.6%, 99.9%)
99.5%
(96.6%, 99.9%)
98.6%
(94.4%, 99.7%)
RestorePrime 100.0%
(NA)
100.0%
(NA)
- -
PrimeAdvanced 99.8%
(98.5%, 100.0%)
99.5%
(97.9%, 99.9%)
98.9%
(96.1%, 99.7%)
98.9%
(96.1%, 99.7%)
PrimeAdvanced
SureScan
MRI
99.6%
(97.0%, 99.9%)
99.6%
(97.0%, 99.9%)
- -
Rechargeable Neurostimulators
Restore 100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
RestoreUltra 100.0%
(NA)
99.6%
(97.2%, 99.9%)
99.1%
(96.3%, 99.8%)
98.1%
(93.6%, 99.4%)
RestoreAdvanced 99.6%
(97.5%, 99.9%)
99.6%
(97.5%, 99.9%)
99.6%
(97.5%, 99.9%)
99.6%
(97.5%, 99.9%)
RestoreSensor 99.6%
(97.4%, 99.9%)
99.1%
(96.1%, 99.8%)
99.1%
(96.1%, 99.8%)
-
RestoreUltra
SureScan MRI
-b - - -
RestoreAdvanced
SureScan MRI
98.2%
(88.1%, 99.7%)
- - -
Restore Sensor
SureScan MRI
99.2%
(98.0%, 99.7%)
99.2%
(98.0%, 99.7%)
- -
Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Name 5 yrs 6 yrs 7 yrs 8 yrs
Primary Cell Neurostimulators
Itrel 3 - - - -
Itrel 4 - - - -
Synergy 97.3%
(91.4%, 99.2%)
97.3%
(91.4%, 99.2%)
97.3%
(91.4%, 99.2%)
-
RestorePrime - - - -
PrimeAdvanced 98.9%
(96.1%, 99.7%)
- - -
PrimeAdvanced
SureScan MRI
- - - -
Rechargeable Neurostimulators
Restore 100.0%
NA
98.3%
(88.5%, 99.8%)
98.3%
(88.5%, 99.8%)
98.3%
(88.5%, 99.8%)
RestoreUltra 96.4%
(89.4%, 98.8%)
94.4%
(85.3%, 97.9%)
- -
RestoreAdvanced 99.6%
(97.5%, 99.9%)
99.6%
(97.5%, 99.9%)
99.6%
(97.5%, 99.9%)
-
RestoreSensor - - - -
RestoreAdvanced
SureScan MRI
- - - -
Restore Sensor
SureScan MRI
- - - -
RestoreUltra
SureScan MRI
- - - -

 

Leads

From June 2004 to the report cut-off date of July 31, 2016, there were 7,909 leads followed in the registry. Differences between the total number of leads versus spinal cord neurostimulators (N=4,731) 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 150,646 months (12,554 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 of Leads (%)
Pisces Octad Compact (3778)a 2,147 (27.1%)
Vectris SureScan MRI Compact (977A2)a 1,917 (24.2%)
Pisces Standard (3487A)a 963 (12.2%)
Pisces Octad Standard (3777)a 821 (10.4%)
Pisces Plus (3888)a 424 (5.4%)
Specify 5-6-5 (39565)b 271 (3.4%)
Pisces Compact (3887)a 192 (2.4%)
Pisces Octad Subcompact (3776)a 184 (2.3%)
Vectris SureScan MRI Subcompact (977A1)a 105 (1.3%)
Specify 2x8 (39286)b 30 (0.4%)
Specify SureScan MRI 5-6-5 (977C1)b 10 (0.1%)
Specify SureScan MRI 2x8 (977C2)b 2 (<0.1%)
Other/Unspecified 186 (2.4%)
Leads No Longer Manufactured
Specify (3998)b 149 (1.9%)
Pisces Z Standard (3890)a 140 (1.8%)
Pisces Z Compact (3891)a 123 (1.6%)
Resume TL (3986A)b 104 (1.3%)
Hinged Specify (3999)b 54 (0.7%)
Resume II (3587A)b 52 (0.7%)
Pisces Z Plus (3892)a 24 (0.3%)
On-Point (3987A)b 9 (0.1%)
SymMix (3982A)b 2 (<0.1%)
Total 7,909 (100%)

a Percutaneous lead
bSurgical lead

Percutaneous leads composed eighty-nine percent (89.0%) of leads in the registry (7,040/7,909), including 39.9% (3,152/7,909) in the Pisces-Octad lead family, 25.6% (2,022/7,909) in the Vectris SureScan MRI lead family, 20.0% (1,579/7,909) in the Pisces-Quad lead family, and 3.6% (287/7,909) in the Pisces-Quad LZ lead family. Over eight percent (8.6%) of leads (683/7,909) were surgical leads. A small percent (2.4%) of leads (186/7,909) were designated as “Other” or were unspecified in the database.

Lead EventsLead Events

There were 885 product performance-related events with an underlying reported etiology related to the lead. This includes 862 events with a lead etiology and 23 events with both a lead and other etiology (including device and non-device etiologies). Of these events, the majority were lead migration/dislodgements (n=500), high impedance (n=207), and lead fracture (n=64). Of the 885 lead events, 757 were the initial product performance event that affected lead survival estimates. There were 702 events in the 7,040 (10.0%) percutaneous leads, 44 events in the 683 (6.4%) surgical leads, and 11 events occurred in a lead with an unknown/other 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:

  • 757 had follow-up time cut-off due to product performance-related events.
  • 4,404 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.
  • 2,748 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 tables below represent annual lead survival and 95% confidence intervals where at least 20 leads contributed to each 3-month interval.

                                                  

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 963
Leads Currently Active in Study 328
Device Events 182
Cumulative Months of Follow-up 28,621
Model 3487A Pisces-Quad: Event Summary Table
Lead Event Total
High impedance 74
Lead migration/dislodgement 51
Low impedance 25
Device stimulation issue 17
Lead fracture 13
Inadequate lead connection 2
Total Lead Events 182
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 89.8%
(86.9%, 92.0%)
464
2 yrs 86.8%
(83.6%, 89.4%)
380
3 yrs 80.0%
(76.1%, 83.3%)
311
4 yrs 73.6%
(69.2%, 77.6%)
224
5 yrs 70.4%
(65.7%, 74.7%)
184
6 yrs 65.3%
(60.1%, 70.1%)
145
7 yrs 62.3%
(56.7%, 67.4%)
107
8 yrs 62.3%
(56.7%, 67.4%)
93
9 yrs 56.1%
(49.5%, 62.1%)
70
10 yrs 52.6%
(45.6%, 59.1%)
59
11 yrs 51.5%
(44.3%, 58.2%)
40
at 141 mo 51.5%
(44.3%, 58.2%)
22

 

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 192
Leads Currently Active in Study 56
Device Events 22
Cumulative Months of Follow-up 4,598
Model 3887 Pisces-Quad: Event Summary Table
Lead Event Total
Lead migration/dislodgement 9
Lead fracture 7
High impedance 3
Device stimulation issue 2
Device lead damage 1
Total Lead Events 22
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 91.5%
(75.8%, 97.2%)
46
2 yrs 81.4%
(66.8%, 90.0%)
49
3 yrs 76.3%
(61.7%, 85.9%)
47
4 yrs 74.8%
(60.3%, 84.7%)
41
5 yrs 72.9%
(58.3%, 83.1%)
36
6 yrs 70.5%
(55.6%, 81.2%)
29
7 yrs 68.0%
(52.8%, 79.2%)
23
at 90 mo 68.0%
(52.8%, 79.2%)
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 424
Leads Currently Active in Study 74
Device Events 34
Cumulative Months of Follow-up 7,935
Model 3888 Pisces-Quad: Event Summary Table
Lead Event Total
Lead migration/dislodgement 24
High impedance 7
Device stimulation issue 2
Lead fracture 1
Total Lead Events 34
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.8%
(88.2%, 95.6%)
136
2 yrs 91.2%
(86.1%, 94.5%)
83
3 yrs 86.2%
(78.6%, 91.2%)
69
4 yrs 80.0%
(70.9%, 86.5%)
59
5 yrs 77.0%
(67.1%, 84.2%)
44
6 yrs 73.1%
(62.1%, 81.4%)
35
7 yrs 73.1%
(62.1%, 81.4%)
29
8 yrs 73.1%
(62.1%, 81.4%)
27
9 yrs 73.1%
(62.1%, 81.4%)
22
10 yrs 73.1%
(62.1%, 81.4%)
22
at 123 mo 73.1%
(62.1%, 81.4%)
22

 

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

View Larger Image


Lead Characteristics
Model Number 3890
FDA Approval Date Sep 2002
Leads Enrolled 140
Leads Currently Active in Study 18
Device Events 10
Cumulative Months of Follow-up 2,986
Model 3890 Pisces-Quad LZ: Event Summary Table
Lead Event Total
Lead migration/dislodgement 4
Device malfunctiona 2
Lead fracture 2
High impedance 2
Total Lead Events 10

a Includes 2 events reported as impedance not measurable.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0%
(NA)
38
2 yrs 97.8%
(85.1%, 99.7%)
51
3 yrs 89.4%
(76.4%, 95.5%)
40
4 yrs 89.4%
(76.4%, 95.5%)
33
5 yrs 83.8%
(68.8%, 92.0%)
22
at 66 mo 83.8%
(68.8%, 92.0%)
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

View Larger Image

Lead Characteristics
Model Number 3891
FDA Approval Date Sep 2002
Leads Enrolled 123
Leads Currently Active in Study 12
Device Events 32
Cumulative Months of Follow-up 2,315
Model 3891 Pisces-Quad LZ: Event Summary Table
Lead Event Total
Lead migration/dislodgement 18
Lead fracture 6
Device stimulation issue 4
Device lead damage 2
High impedance 2
Total Lead Events 32
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 81.7%
(71.4%, 88.5%)
56
2 yrs 78.7%
(67.9%, 86.2%)
37
at 30 mo 63.9%
(49.3%, 75.3%)
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

View Larger Image

Lead Characteristics
Model Number 3776
FDA Approval Date Nov 2005
Leads Enrolled 184
Leads Currently Active in Study 37
Device Events 14
Cumulative Months of Follow-up 3,816
Model 3776 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgement 10
High impedance 2
Device stimulation issue 1
Lead fracture 1
Total Lead Events 14
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 91.6%
(85.4%, 95.3%)
83
2 yrs 91.6%
(85.4%, 95.3%)
61
3 yrs 91.6%
(85.4%, 95.3%)
38
4 yrs 89.0%
(79.9%, 94.2%)
23
5 yrs 89.0%
(79.9%, 94.2%)
20
at 63 mo 89.0%
(79.9%, 94.2%)
20

 

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

View Larger Image

Lead Characteristics
Model Number 3777
FDA Approval Date Apr 2005
Leads Enrolled 821
Leads Currently Active in Study 149
Device Events 60
Cumulative Months of Follow-up 17,564
Model 3777 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgement 40
Device stimulation issue 7
High impedance 7
Device lead damage 2
Lead fracture 2
Low impedance 2
Total Lead Events 60
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 93.0%
(90.5%, 94.9%)
423
2 yrs 89.7%
(86.6%, 92.2%)
265
3 yrs 89.7%
(86.6%, 92.2%)
157
4 yrs 89.1%
(85.5%, 91.8%)
100
5 yrs 88.1%
(83.9%, 91.2%)
72
6 yrs 85.2%
(79.1%, 89.7%)
55
7 yrs 85.2%
(79.1%, 89.7%)
36
8 yrs 79.4%
(68.2%, 87.0%)
25
9 yrs 73.0%
(58.9%, 83.0%)
32
at 117 mo 73.0%
(58.9%, 83.0%)
23

 

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

View Larger Image

Lead Characteristics
Model Number 3778
FDA Approval Date Apr 2005
Leads Enrolled 2,147
Leads Currently Active in Study 428
Device Events 257
Cumulative Months of Follow-up 48,813
Model 3778 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgement 194
High impedance 34
Lead fracture 15
Device stimulation issue 6
Medical device complicationa 4
Device malfunctionb 2
Impedance increased 1
Low impedance 1
Total Lead Events 257

a Includes 2 events reported as lead lost capability of stimulation and 2 events of open circuit on lead.
b Includes 2 events reported as lead electrodes not functional.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 89.9%
(88.3%, 91.3%)
1,198
2 yrs 86.4%
(84.5%, 88.1%)
762
3 yrs 84.3%
(82.1%, 86.2%)
498
4 yrs 83.8%
(81.5%, 85.8%)
318
5 yrs 80.4%
(77.3%, 83.0%)
212
6 yrs 77.7%
(73.9%, 81.1%)
126
7 yrs 75.5%
(70.9%, 79.5%)
68
8 yrs 71.4%
(64.6%, 77.1%)
32
at 102 mo 71.4%
(64.6%, 77.1%)
24

 

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 977A1 Vectris SureScan MRI 1x8 Subcompact: Survival from Lead Events

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

Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Survival from Lead Events

View Larger Image

Lead Characteristics
Model Number 977A1
FDA Approval Date Mar 2013
Leads Enrolled 105
Leads Currently Active in Study 75
Device Events 4
Cumulative Months of Follow-up 1,023
Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Event Summary Table
Lead Event Total
Device lead fracture 2
Lead migration/dislodgement 2
Total Lead Events 4
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 97.1%
(89.1%, 99.3%)
43
at 18 mo 91.1%
(76.6%, 96.8%)
22

 

Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Specifications

Device Name Vectris SureScan MRI
1x8 Subcompact
Model 977A1 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) 1.5
Array Length (mm) 34.5

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

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

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

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Lead Characteristics
Model Number 977A2
FDA Approval Date Mar 2013
Leads Enrolled 1,917
Leads Currently Active in Study 1,449
Device Events 86
Cumulative Months of Follow-up 16,566
Model 977A2 Vectris SureScan MRI 1x8 Compact: Event Summary Table
Lead Event Total
Lead migration/dislodgement 68
High impedance 12
Lead fracture 4
Impedance increased 1
Low impedance 1
Total Lead Events 86
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 94.2%
(92.6%, 95.4%)
595
2 yrs 89.9%
(86.8%, 92.4%)
138
at 30 mo 89.9%
(86.8%, 92.4%)
37

 

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

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 104
Leads Currently Active in Study 35
Device Events 19
Cumulative Months of Follow-up 2,893
Model 3986A Resume TL: Event Summary Table
Lead Event Total
High impedance 10
Device connection issue 2
Device stimulation issue 2
Low impedance 2
Lead migration/dislodgement 2
Lead fracture 1
Total Lead Events 19
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 84.0%
(72.9%, 90.8%)
47
2 yrs 84.0%
(72.9%, 90.8%)
36
3 yrs 81.7%
(69.7%, 89.3%)
29
4 yrs 81.7%
(69.7%, 89.3%)
26
5 yrs 81.7%
(69.7%, 89.3%)
20
at 63 mo 81.7%
(69.7%, 89.3%)
20

 

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 149
Leads Currently Active in Study 20
Device Events 10
Cumulative Months of Follow-up 2,992
Model 3998 Specify: Event Summary Table
Lead Event Total
High impedance 4
Lead fracture 3
Lead migration/dislodgement 2
Device stimulation issue 1
Total Lead Events 10
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 97.0%
(88.6%, 99.2%)
59
2 yrs 91.6%
(80.8%, 96.4%)
41
at 33 mo 88.5%
(75.3%, 94.8%)
26

 

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 271
Leads Currently Active in Study 120
Device Events 11
Cumulative Months of Follow-up 4,441
Model 39565 Specify: Event Summary Table
Lead Event Total
Lead migration/dislodgement 10
High impedance 1
Total Lead Events 11
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 96.6%
(93.0%, 98.4%)
136
2 yrs 95.7%
(91.5%, 97.9%)
74
3 yrs 95.7%
(91.5%, 97.9%)
29
at 39 mo 95.7%
(91.5%, 97.9%)
24

 

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

Lead Survival SummaryLead Survival Summary

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 963 328 182 28,621
3887 Pisces-Quad Jan 1997 192 56 22 4,598
3888 Pisces-Quad Nov 1992 424 74 34 7,935
3890 Pisces-Quad LZ Sep 2002 140 18 10 2,986
3891 Pisces-Quad LZ Sep 2002 123 12 32 2,315
3776 Pisces-Octad Nov 2005 184 37 14 3,816
3777 Pisces-Octad Apr 2005 821 149 60 17,564
3778 Pisces-Octad Apr 2005 2,147 428 257 48,813
977A1 Vectris SureScan Mar 2013 105 75 4 1,023
977A2 Vectris SureScan Mar 2013 1,917 1,449 86 16,566
Surgical Leads
3986A Resume TL Apr 1995b 104 35 19 2,893
3998 Specify Feb 1998 149 20 10 2,992
39565 Specify Jun 2007 271 120 11 4,441

a There were a total of 885 lead-related events reported to the registry, but only 741 events included in this summary table. The remaining lead-related events occurred in lead models for which no device survival data are presented due to an insufficient number of enrolled devices (n=5), leads with an unknown model number (n=11), or were subsequent device events (i.e. additional events that occurred after the survival censoring event) 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 89.8%
(86.9%, 92.0%)
86.8%
(83.6%, 89.4%)
80.0%
(76.1%, 83.3%)
73.6%
(69.2%, 77.6%)
3887 Pisces-Quad 91.5%
(75.8%, 97.2%)
81.4%
(66.8%, 90.0%)
76.3%
(61.7%, 85.9%)
74.8%
(60.3%, 84.7%)
3888 Pisces-Quad 92.8%
(88.2%, 95.6%)
91.2%
(86.1%, 94.5%)
86.2%
(78.6%, 91.2%)
80.0%
(70.9%, 86.5%)
3890 Pisces-Quad LZ 100.0%
(NA)
97.8%
(85.1%, 99.7%)
89.4%
(76.4%, 95.5%)
89.4%
(76.4%, 95.5%)
3891 Pisces-Quad LZ 81.7%
(71.4%, 88.5%)
78.7%
(67.9%, 86.2%)
- -
3776 Pisces-Octad 91.6%
(85.4%, 95.3%)
91.6%
(85.4%, 95.3%)
91.6%
(85.4%, 95.3%)
89.0%
(79.9%, 94.2%)
3777 Pisces-Octad 93.0%
(90.5%, 94.9%)
89.7%
(86.6%, 92.2%)
89.7%
(86.6%, 92.2%)
89.1%
(85.5%, 91.8%)
3778 Pisces-Octad 89.9%
(88.3%, 91.3%)
86.4%
(84.5%, 88.1%)
84.3%
(82.1%, 86.2%)
83.8%
(81.5%, 85.8%)
977A1 Vectris SureScan 97.1%
(89.1%, 99.3%)
- - -
977A2 Vectris SureScan 94.2%
(92.6%, 95.4%)
89.9%
(86.8%, 92.4%)
- -
Surgical Leads
3986A Resume TL 84.0%
(72.9%, 90.8%)
84.0%
(72.9%, 90.8%)
81.7%
(69.7%, 89.3%)
81.7%
(69.7%, 89.3%)
3998 Specify 97.0%
(88.6%, 99.2%)
91.6%
(80.8%, 96.4%)
- -
39565 Specify 96.6%
(93.0%, 98.4%)
95.7%
(91.5%, 97.9%)
95.7%
(91.5%, 97.9%)
-

 

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 70.4%
(65.7%, 74.7%)
65.3%
(60.1%, 70.1%)
62.3%
(56.7%, 67.4%)
62.3%
(56.7%, 67.4%)
3887 Pisces-Quad 72.9%
(58.3%, 83.1%)
70.5%
(55.6%, 81.2%)
68.0%
(52.8%, 79.2%)
-
3888 Pisces-Quad 77.0%
(67.1%, 84.2%)
73.1%
(62.1%, 81.4%)
73.1%
(62.1%, 81.4%)
73.1%
(62.1%, 81.4%)
3890 Pisces-Quad LZ 83.8%
(68.8%, 92.0%)
- - -
3891 Pisces-Quad LZ - - - -
3776 Pisces-Octad 89.0%
(79.9%, 94.2%)
- - -
3777 Pisces-Octad 88.1%
(83.9%, 91.2%)
85.2%
(79.1%, 89.7%)
85.2%
(79.1%, 89.7%)
79.4%
(68.2%, 87.0%)
3778 Pisces-Octad 80.4%
(77.3%, 83.0%)
77.7%
(73.9%, 81.1%)
75.5%
(70.9%, 79.5%)
71.4%
(64.6%, 77.1%)
977A1 Vectris SureScan - - - -
977A2 Vectris SureScan - - - -
Surgical Leads
3986A Resume TL 81.7%
(69.7%, 89.3%)
- - -
3998 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 56.1%
(49.5%, 62.1%)
52.6%
(45.6%, 59.1%)
51.5%
(44.3%, 58.2%)
3887 Pisces-Quad - - -
3888 Pisces-Quad 73.1%
(62.1%, 81.4%)
73.1%
(62.1%, 81.4%)
-
3890 Pisces-Quad LZ - - -
3891 Pisces-Quad LZ - - -
3776 Pisces-Octad - - -
3777 Pisces-Octad 73.0%
(58.9%, 83.0%)
- -
3778 Pisces-Octad - - -
977A1 Vectris SureScan - - -
977A2 Vectris SureScan - - -
Surgical Leads
3986A Resume TL - - -
3998 Specify - - -
39565 Specify - - -

 

Extensions

From June 2004 to the report cut-off date of July 31, 2016, there were 3,275 extensions followed in the registry. Differences between the total number of extensions versus spinal cord neurostimulators (N=4,731) were due to the fact that some systems did not use an extension. The aggregate prospective follow-up time for all extensions was 77,026 months (6,419 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 Model
Model Number of Extensions (%)
37081 (1x8) 1,377 (42.0%)
37082 (bifurcated stretch coil) 614 (18.7%)
37083 (single stretch coil) 222 (6.8%)
Other/Unspecified 14 (0.4%)
Extensions No Longer Manufactured
7489 (Low profile quadripolar) 746 (22.8%)
7495 (quadripolar in-line) 264 (8.1%)
7472 (bifurcated 1x8) 21 (0.6%)
7496 (quadripolar) 9 (0.3%)
7471 (1x8) 8 (0.2%)
Total 3,275 (100%)

Extension EventsExtension Events

There were 31 product performance-related events with an underlying reported etiology related to the extension. This includes 27 events with an extension etiology and 4 events with both an extension and other etiology (including device and non-device etiologies). Of these events, the majority were extension fractures (n=15). Of the 31 events, 27 were the initial product performance event that affected extension 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 extensions:

  • 27 had follow-up time cut-off due to product performance-related events.
  • 2,433 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.
  • 815 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.

                                
   

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

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Extension Characteristics
Model Number 37081
FDA Approval Date Apr 2005
Extensions Enrolled 1,377
Extensions Currently Active in Study 423
Device Events 9
Cumulative Months of Follow-up 27,730
Model 37081 Extension: Event Summary Table
Extension Event Total
Extension fracture 6
Extension migration 1
High impedance 1
Low impedance 1
Total Extension Events 9
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.8%
(99.1%, 99.9%)
707
2 yrs 99.1%
(97.9%, 99.6%)
424
3 yrs 98.5%
(97.0%, 99.3%)
246
4 yrs 98.5%
(97.0%, 99.3%)
160
5 yrs 98.5%
(97.0%, 99.3%)
113
6 yrs 98.5%
(97.0%, 99.3%)
74
7 yrs 98.5%
(97.0%, 99.3%)
49
8 yrs 98.5%
(97.0%, 99.3%)
29
at 99 mo 98.5%
(97.0%, 99.3%)
25

 

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 614
Extensions Currently Active in Study 178
Device Events 5
Cumulative Months of Follow-up 18,102
Model 37082 Extension: Event Summary Table
Extension Event Total
Device connection issue 2
Extension fracture 2
Paraesthesiaa 1
Total Extension Events 5

a Reported as shocking sensation at battery/extension connection.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.6%
(98.3%, 99.9%)
403
2 yrs 99.3%
(97.9%, 99.8%)
274
3 yrs 99.3%
(97.9%, 99.8%)
176
4 yrs 99.3%
(97.9%, 99.8%)
125
5 yrs 99.3%
(97.9%, 99.8%)
98
6 yrs 99.3%
(97.9%, 99.8%)
76
7 yrs 96.4%
(89.1%, 98.8%)
51
8 yrs 96.4%
(89.1%, 98.8%)
34
at 105 mo 96.4%
(89.1%, 98.8%)
21

 

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 222
Extensions Currently Active in Study 51
Device Events 5
Cumulative Months of Follow-up 5,691
Model 37083 Extension: Event Summary Table
Extension Event Total
Extension fracture 3
Device failurea 1
Extension migration 1
Total Extension Events 5

a Reported as extension failure

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.1%
(94.1%, 99.9%)
122
2 yrs 97.3%
(92.0%, 99.1%)
97
3 yrs 96.2%
(90.0%, 98.6%)
54
4 yrs 96.2%
(90.0%, 98.6%)
42
5 yrs 96.2%
(90.0%, 98.6%)
31
6 yrs 96.2%
(90.0%, 98.6%)
28
7 yrs 96.2%
(90.0%, 98.6%)
26
at 87 mo 96.2%
(90.0%, 98.6%)
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

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 746
Extensions Currently Active in Study 97
Device Events 4
Cumulative Months of Follow-up 17,761
Model 7489 Extension: Event Summary Table
Extension Event Total
Extension fracture 2
Extension migration 1
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 99.1% 
(96.5%, 99.8%)
294
2 yrs 99.1% 
(96.5%, 99.8%)
290
3 yrs 98.3% 
(95.6%, 99.4%)
205
4 yrs 98.3% 
(95.6%, 99.4%)
138
5 yrs 98.3% 
(95.6%, 99.4%)
103
6 yrs 98.3% 
(95.6%, 99.4%)
80
7 yrs 98.3% 
(95.6%, 99.4%)
63
8 yrs 98.3% 
(95.6%, 99.4%)
61
9 yrs 98.3% 
(95.6%, 99.4%)
60
10 yrs 98.3% 
(95.6%, 99.4%)
53
11 yrs 98.3% 
(95.6%, 99.4%)
42
at 138 mo 98.3% 
(95.6%, 99.4%)
30

 

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

Extension Survival SummaryExtension Survival Summary

 

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
1,377 423 9 27,730
37082 37082 Mar
2006
614 178 5 18,102
37083 37083 Sep
2005
222 51 5 5,691
7489 7489 Oct
2002
746 97 4 17,761

a There were a total of 31 extension-related events reported to the registry, but only 23 events are included in this summary table. The remaining extension-related events occurred in an extension model for which no device survival data is presented due to an insufficient number of enrolled devices (n=4), or were subsequent device events (i.e. additional events that occurred after the survival censoring event)  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 99.8%
(99.1%, 99.9%)
99.1%
(97.9%, 99.6%)
98.5%
(97.0%, 99.3%)
98.5%
(97.0%, 99.3%)
98.5%
(97.0%, 99.3%)
37082 99.6%
(98.3%, 99.9%)
99.3%
(97.9%, 99.8%)
99.3%
(97.9%, 99.8%)
99.3%
(97.9%, 99.8%)
99.3%
(97.9%, 99.8%)
37083 99.1%
(94.1%, 99.9%)
97.3%
(92.0%, 99.1%)
96.2%
(90.0%, 98.6%)
96.2%
(90.0%, 98.6%)
96.2%
(90.0%, 98.6%)
7489 99.1%
(96.5%, 99.8%)
99.1%
(96.5%, 99.8%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)

 

Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Number 6 yrs 7 yrs 8 yrs 9 yrs 10 yrs 11 yrs
37081 98.5%
(97.0%, 99.3%)
98.5%
(97.0%, 99.3%)
98.5%
(97.0%, 99.3%)
- - -
37082 99.3%
(97.9%, 99.8%)
96.4%
(89.1%, 98.8%)
96.4%
(89.1%, 98.8%)
- - -
37083 96.2%
(90.0%, 98.6%)
96.2%
(90.0%, 98.6%)
- - - -
7489 98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)

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

United States