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Spinal Cord Stimulation Systems

Spinal Cord Stimulation Systems
Print Tool

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, 2015. Seventy-two centers enrolled and contributed patients.


Patients

Of the 3,797 total spinal cord stimulation patients enrolled, 44.8% were implanted for the treatment of other pain indications, 43.4% were implanted for the treatment of failed back pain, 10.8% were implanted for the treatment of complex regional pain syndrome (CRPS), and 1.0% 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 1,701 (44.8%)
Other chronic pain 716 (18.9%)
Radicular pain syndrome 533 (14.0%)
Other 219 (5.8%)
Degenerative disc disease 144 (3.8%)
Cervical pain 28 (0.7%)
Traumatic nerve injury 24 (0.6%)
Diabetic neuropathy 18 (0.5%)
Post Herpetic Neuralgia 9 (0.2%)
Facial pain 6 (0.2%)
Epidural Fibrosis 3 (0.1%)
Post herniorrhaphy pain 1 (<0.1%)
Failed Back Pain 1,648 (43.4%)
Postlaminectomy pain 685 (18.0%)
Failed Back Syndrome (FBS) 554 (14.6%)
Combination back and leg pain 308 (8.1%)
Multiple Back Operations 74 (1.9%)
Arachnoiditis 21 (0.6%)
Unsuccessful Disc Surgery 6 (0.2%)
CRPS 410 (10.8%)
CRPS I 308 (8.1%)
CRPS II 102 (2.7%)
Not Specified 38 (1.0%)
Total Patients 3,797

a Refer to product labeling for approved indications.

Event Summary

There were 2,213 events reported between June 2004 and July 31, 2015 in patients with spinal cord stimulation systems. Of these events, 38.9% (860/2,213) were categorized as product performance-related and are presented within this report. The 860 product performance events occurred in 405 of the 3,797 total patients (10.7%) enrolled. In addition, there were 1,353 non-product performance events. There were also 103 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=3,797)
Lead migration/dislodgment 425 222 5.9%
Lead high impedance 176 79 2.1%
Lead fracture 56 37 1.0%
Device stimulation issuec 47 26 0.7%
Lead low impedance 31 10 0.3%
Neurostimulator unable to recharged 26 24 0.6%
Medical device complicatione 17 12 0.3%
Device malfunctionf 15 13 0.3%
Extension fracture 14 9 0.2%
Device breakageg 12 12 0.3%
Device lead damage 7 5 0.1%
Battery recharge issued 5 5 0.1%
Device component issueh 4 3 0.1%
Device failurei 4 3 0.1%
Extension migration 4 2 0.1%
Therapeutic product ineffective 3 2 0.1%
Device battery issue 2 2 0.1%
Device connection issue 2 2 0.1%
Device lead issue 2 1 <0.1%
Inadequate lead connection 2 1 <0.1%
Paraesthesiaj 2 2 0.1%
Antenna cable breakage 1 1 <0.1%
Broken bond wire 1 1 <0.1%
Device kink 1 1 <0.1%
Device telemetry issue 1 1 <0.1%
Totals 860 405 10.7%

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 2,489 patients that used rechargeable SCS neurostimulators in the registry. A total of 1.2% (29/2,489) of patients with a rechargeable SCS neurostimulator experienced a recharging unable to recharge or battery recharge issue product performance 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 hybrid anomaly, 1 loose anchor, 1 programmer error message, 1 unknown problem with extension, 1 defective patient programmer, 1 excessive heating of charging unit.
f Includes 2 events for charger malfunction, 2 events for impedance not measurable, 2 events for non-functional lead electrodes, 2 patient programmer malfunctions, 2 antenna malfunctions, 1 malfunctioning programmer, 1 neurostimulator malfunction, 1 event for lead impedance changes, 1 event for neurostimulator stopped working abruptly, and 1 event for error message on programmer.
g 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.
h Includes 2 events for lead fractures and migration, 1 damaged antenna cord, and 1 faulty antenna.
i Includes 2 events for lead failure, 1 event for failure of lead electrodes, and 1 extension failure.
j Includes 1 event for shocking sensation at battery site and 1 shocking sensation at battery/extension connection.

A total of 729 (84.8%) of the 860 product performance events were related to the lead, 37 (4.3%) were related to "other device", 34 (4.0%) were related to “multiple etiologies”, which includes events where at least one device and one non-device etiology was indicated, 19 (2.2%) were related to the neurostimulator, 18 (2.1%) were related to the extension, 13 (1.5%) were related to recharging process, 5 (0.6%) were related to programming/stimulation, 2 (0.2%) were related to incisional site/device tract, 2 (0.2%) were related to other etiology, and 1 (0.1%) was 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 410
   Device stimulation issuec 223
   Battery recharge issued 64
   Device battery issuee 27
   Neurostimulator unable to rechargef 24
   Neurostimulator migration 22
   Neurostimulator inversion 17
   Device use error 9
   Otherg 24
Therapeutic and nontherapeutic effects (excluding toxicity) 333
   Therapeutic product ineffective 147
   Therapeutic response decreased 124
   No therapeutic response 58
   Otherg 4
Administration site reactions 204
   Implant site pain 139
   Implant site erythema 20
   Implant site erosion 13
   Implant site extravasation 12
   Otherg 20
Infections - pathogen unspecified 115
   Implant site infection 85
   Infection 15
   Wound infection 9
   Otherg 6
General system disorders not elsewhere classified (NEC) 76
   Pain 60
   No anomaly found by RPAh 9
   Otherg 7
Procedural related injuries and complications NEC 45
   Wound dehiscence 7
   Incision site pain 6
   Seroma 6
   Incision site erythema 5
   Otherg 21
Musculoskeletal and connective tissue disorders NEC 40
   Pain in extremity 21
   Back pain 14
   Otherg 5
Neurological disorders NEC 32
   Paraesthesia 19
   Otherg 13
Complications associated with device 20
   Medical device discomfort 14
   Otherg 6
Muscle disorders 9
   Muscle spasms 6
   Otherg 3
Headaches 8
   Headache 7
   Otherg 1
Tissue disorders NEC 5
   Impaired healing 5
Not Codedi 13
Otherg 43
Total 1,353

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 or Medtronic’s own coding system terms for events that do not exist in the MedDRA dictionary.
c Event reported by the physician with an etiology that was either not device related or had no associated device event.
d Event reported as recharge issues not due to a device malfunction.
e Event reported as battery discharge or depletion not due to a device malfunction.
f Patient was unable to recharge due to an issue not related to the device.
g Composed of event codes with fewer than 5 events each.
h 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).
i Events that had not been MedDRA-coded at the time of the report cut-off.

There were 103 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, 52 (50.5%) of the deaths occurred in patients receiving therapy for pain indications in the “other” category, 43 (41.8%) for failed back pain, and 8 (7.8%) for CRPS.

Death by Primary Indication
Primary Indicationa N (%)
Other 52 (50.5%)
Failed Back Pain 43 (41.8%)
CRPS 8 (7.8%)
Total 103 (100%)

a Refer to product labeling for approved indications

Spinal Cord Stimulators

From June 2004 to the report cut-off date of July 31, 2015, 4,176 spinal cord stimulators were followed in the registry. The difference between the total number of patients (N=3,797) 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 68,753 months (5,729 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 661 (15.8%)
RestoreSensor SureScan MRI 637 (15.3%)
RestoreUltra 581 (13.9%)
Synergy 461 (11.0%)
Restore 448 (10.7%)
RestoreAdvanced 364 (8.7%)
RestoreSensor 360 (8.6%)
PrimeAdvanced SureScan MRI 267 (6.4%)
Itrel 3 96 (2.3%)
RestoreAdvanced SureScan MRI 70 (1.7%)
RestorePrime 57 (1.4%)
Itrel 4 54 (1.3%)
Synergy Versitrel 52 (1.2%)
RestoreUltra SureScan MRI 29 (0.7%)
SynergyPlus+ 16 (0.4%)
SynergyCompact 8 (0.2%)
Other/Unspecified 15 (0.4%)
Total 4,176 (100%)

Spinal Cord Stimulator Events Spinal Cord Stimulator Events

There were 28 product performance-related events with an underlying reported etiology related to spinal cord stimulator function. This includes 19 events with a stimulator etiology and 9 events with both a stimulator and other etiology (including device and non-device etiologies). Of these, 21 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 238/927 (25.7%). 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 28 spinal cord stimulator events was confirmed by Medtronic RPA as a broken bond wire. The remaining 27 spinal cord stimulators with performance-related events were not returned to Medtronic RPA but were assigned as device related by the physician as neurostimulator unable to recharge (n=8), lead high impedance (n=6), battery recharge issue (n=3), medical device complication (n=3), device stimulation issue (n=2), device battery issue (n=2), device malfunction (n=1), extension migration (n=1), or lead migration/dislodgement (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:

  • 21 had follow-up time cut-off due to product performance-related events.
  • 2,654 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.
  • 1,501 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.

           

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 1,425
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)
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 10
Device Events 3
Cumulative Months of Follow-up 9,281
Model 7427 Synergy: Event Summary Table
Neurostimulator Event Total
Device stimulation issue 1
Broken bond wire 1
Lead migration/dislodgment 1
Total Neurostimulator Events 3
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 207
2 yrs 100.0% (NA) 174
3 yrs 100.0% (NA) 118
4 yrs 99.1%
(93.9%, 99.9%)
78
5 yrs 97.8%
(91.3%, 99.5%)
44
6 yrs 97.8%
(91.3%, 99.5%)
32
at 81 mo 97.8%
(91.3%, 99.5%)
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 7427V Synergy Versitrel: Survival from Spinal Cord Stimulator Events

Spinal Cord Stimulator Characteristics
Model Name Synergy Versitrel
FDA Approval Date Dec 2001
Neurostimulators Enrolled 52
Neurostimulators Currently Active in Study 14
Device Events 0
Cumulative Months of Follow-up 724
Time Interval Survival
(95% Confidence Interval)
Sample Size
at 6 mo 100.0% (NA) 23
at 9 mo 100.0% (NA) 22

 

Model 7427V Synergy Versitrel: Specifications

Height 61 mm (2.4 in) ppr-7427V
Width 61 mm (2.4 in)
Thinness 15 mm (0.6 in)
Volume 40 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 57
Neurostimulators Currently Active in Study 2
Device Events 0
Cumulative Months of Follow-up 1,240
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 37
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)
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 661
Neurostimulators Currently Active in Study 148
Device Events 2
Cumulative Months of Follow-up 10,988
Model 37702 PrimeAdvanced: Event Summary Table
Neurostimulator Event Total
Device stimulation issue 1
Device battery issue 1
Total Neurostimulator Events 2
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.8%
(98.4%,100.0%)
337
2 yrs 99.8%
(98.4%,100.0%)
175
3 yrs 99.0%
(95.5%,99.8%)
77
4 yrs 99.0%
(95.5%,99.8%)
38
at 54 mo 99.0%
(95.5%,99.8%)
22

 

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 448
Neurostimulators Currently Active in Study 21
Device Events 4
Cumulative Months of Follow-up 12,815
Model 37711 Restore: Event Summary Table
Neurostimulator Event Total
Neurostimulator unable to recharge 2
Device battery issue 1
Battery recharge issue 1
Total Neurostimulator Events 4
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) 70
6 yrs 98.3%
(88.3%, 99.8%)
53
7 yrs 98.3%
(88.3%, 99.8%)
40
8 yrs 94.9%
(80.0%, 98.8%)
24

 

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 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 581
Neurostimulators Currently Active in Study 106
Device Events 5
Cumulative Months of Follow-up 12,303
Model 37712 RestoreUltra: Event Summary Table
Neurostimulator Event Total
Neurostimulator unable to recharge 2
Device malfunctiona 1
Medical device complicationb 1
Lead high impedance 1
Total Neurostimulator Events 5

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

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.8%
(98.6%, 100.0%)
325
2 yrs 99.4%
(97.3%, 99.9%)
182
3 yrs 98.8%
(96.1%, 99.6%)
126
4 yrs 97.8%
(93.2%, 99.3%)
80
5 yrs 97.8%
(93.2%, 99.3%)
42
at 69 mo 97.8%
(93.2%, 99.3%)
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 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 364
Neurostimulators Currently Active in Study 94
Device Events 2
Cumulative Months of Follow-up 8,940
Model 37713 RestoreAdvanced: Event Summary Table
Neurostimulator Event Total
Medical device complicationa 1
Battery recharge issue 1
Total Neurostimulator Events 2

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%)
219
2 yrs 99.6%
(97.5%, 99.9%)
143
3 yrs 99.6%
(97.5%, 99.9%)
88
4 yrs 99.6%
(97.5%, 99.9%)
57
5 yrs 99.6%
(97.5%, 99.9%)
42
6 yrs 96.8%
(83.0%, 99.4%)
28
at 81 mo 96.8%
(83.0%, 99.4%)
21

 

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 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 360
Neurostimulators Currently Active in Study 238
Device Events 3
Cumulative Months of Follow-up 4,598
Model 37714 RestoreSensor: Event Summary Table
Neurostimulator Event Total
Neurostimulator unable to recharge 2
Battery recharge issue 1
Total Neurostimulator Events 3
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.6%
(96.9%, 99.9%)
171
2 yrs 98.2%
(94.3%, 99.4%)
60
at 30 mo 98.2%
(94.3%, 99.4%)
28

 

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

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

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

Model 97714 RestoreSensor: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name RestoreSensor SureScan MRI
FDA Approval Date Mar 2013
Neurostimulators Enrolled 637
Neurostimulators Currently Active in Study 552
Device Events 2
Cumulative Months of Follow-up 3,409
Model 97714 RestoreSensor SureScan MRI: Event Summary Table
Neurostimulator Event Total
Neurostimulator unable to recharge 2
Total Neurostimulator Events 2
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.4%
(97.7%, 99.9%)
108
at 15 mo 99.4%
(97.7%, 99.9%)
56

 

Model 97714 RestoreSensor SureScan MRI: Specifications

Height 54 mm (2.1 in) ppr-97714
Width 54 mm (2.1 in)
Thinness 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 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 1,425
Synergy Synergy Nov
1999
461 10 3 9,281
Synergy
Versitrel
Synergy Dec
2001
52 14 0 724
Restore
Prime
Restore Mar
2006
57 2 0 1,240
Prime
Advanced
Prime
Advanced
Jul
2006
661 148 2 10,988
Rechargeable Neurostimulators
Restore Restore Apr
2005
448 21 4 12,815
Restore
Ultra
Restore Jan
2008
581 106 5 12,303
Restore
Advanced
Restore Jul
2006
364 94 2 8,940
Restore
Sensor
Restore Nov
2011
360 238 3 4,598
Restore
Sensor
SureScan
MRI
Restore Mar
2013
637 552 2 3,409

a There were 28 neurostimulator-related events reported to the registry, but only 21 events included in this summary table. The remaining neurostimulator related events were subsequent events that did not affect the device survival estimates.
b Synergy Versitrel had device survival probability of 100% at 9 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
- -
Synergy 100.0%
NA
100.0%
NA
100.0%
NA
99.1%
(93.9%, 99.9%)
SynergyVersitrel -b - - -
RestorePrime 100.0%
NA
100.0%
NA
- -
PrimeAdvanced 99.8%
(98.4%, 100.0%)
99.8%
(98.4%, 100.0%)
99.0%
(95.5%, 99.8%)
99.0%
(95.5%, 99.8%)
Rechargeable Neurostimulators
Restore 100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
RestoreUltra 99.8%
(98.6%, 100.0%)
99.4%
(97.3%, 99.9%)
98.8%
(96.1%, 99.6%)
97.8%
(93.2%, 99.3%)
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%
(96.9%, 99.9%)
98.2%
(94.3%, 99.4%)
- -
RestoreSensor
SureScan MRI
99.4%
(97.7%, 99.9%)
- - -
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 - - - -
Synergy 97.8%
(91.3%, 99.5%)
97.8%
(91.3%, 99.5%)
- -
SynergyVersitrel - - - -
RestorePrime - - - -
PrimeAdvanced - - - -
Rechargeable Neurostimulators
Restore 100.0%
NA
98.3%
(88.3%, 99.8%)
98.3%
(88.3%, 99.8%)
94.9%
(80.0%, 98.8%)
RestoreUltra 97.8%
(93.2%, 99.3%)
- - -
RestoreAdvanced 99.6%
(97.5%, 99.9%)
96.8%
(83.0%, 99.4%)
- -
RestoreSensor - - - -
RestoreSensor
SureScan MRI
- - - -

a There were 28 neurostimulator-related events reported to the registry, but only 21 events included in this summary table. The remaining neurostimulator related events were subsequent events that did not affect the device survival estimates.
b Synergy Versitrel had device survival probability of 100% at 9 months of follow-up.

Leads

From June 2004 to the report cut-off date of July 31, 2015, there were 7,054 leads followed in the registry. Differences between the total number of leads versus spinal cord stimulators (N=4,176) 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 127,844 months (10,654 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 2,121 (30.1%)
977A2 1,330 (18.9%)
3487A 937 (13.3%)
3777 792 (11.2%)
3888 408 (5.8%)
39565 236 (3.3%)
3776 183 (2.6%)
3887 176 (2.5%)
3998 148 (2.1%)
3890 137 (1.9%)
3891 119 (1.7%)
3986A 98 (1.4%)
977A1 83 (1.2%)
3999 54 (0.8%)
3587A 50 (0.7%)
39286 23 (0.3%)
3892 22 (0.3%)
3987A 7 (0.1%)
3982A 2 (<0.1%)
Other/Unspecified 128 (1.8%)
Total 7,054 (100%)

Over eighty-nine percent (89.4%) of leads in the registry were percutaneous leads (6,308/7,054) including 43.9% (3,096/7,054) in the Pisces-Octad lead family, 21.6% (1,521/7,054) in the Pisces-Quad lead family, 20.0% (1,413/7,054) in the Vectris SureScan MRI lead family, and 3.9% (278/7,054) in the Pisces-Quad LZ lead family. Over eight percent (8.8%) of leads (618/7,054) were surgical leads. A small number of leads (128/7,054) were designated as “other” (1.8%).

Lead EventsLead Events

There were 748 product performance-related events with an underlying reported etiology related to the lead. This includes 729 events with a lead etiology and 19 events with both a lead and other etiology (including device and non-device etiologies). Of these events, the majority were lead migration/dislodgements (n=421), high impedance (n=161), and lead fracture (n=56). Of the 748 lead events, 644 were the first event attributable to an enrolled lead: 606 events in 6,436 (9.4%) percutaneous leads, 38 events in 618 (6.1%) surgical leads, and 3 events occurred in 128 (2.3%) leads 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:

  • 644 had follow-up time cut-off due to product performance-related events.
  • 3,818 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.
  • 2,592 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 table below represents annual lead survival and 95% confidence intervals where at least 20 leads contributed to each 3-month interval. 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 937
Leads Currently Active in Study 331
Device Events 162
Cumulative Months of Follow-up 26,143
Model 3487A Pisces-Quad: Event Summary Table
Lead Event Total
Lead high impedance 60
Lead migration/dislodgment 46
Lead low impedance 23
Device stimulation issue 17
Lead fracture 13
Inadequate lead connection 2
Therapeutic product ineffective 1
Total Lead Events 162
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 90.1%
(87.2%, 92.4%)
451
2 yrs 87.0%
(83.8%, 89.7%)
364
3 yrs 79.9%
(75.8%, 83.3%)
287
4 yrs 73.1%
(68.5%, 77.2%)
202
5 yrs 70.4%
(65.4%, 74.7%)
163
6 yrs 65.8%
(60.3%, 70.7%)
122
7 yrs 63.4%
(57.6%, 68.7%)
100
8 yrs 63.4%
(57.6%, 68.7%)
70
9 yrs 61.3%
(55.0%, 67.1%)
58
10 yrs 56.5%
(48.9%, 63.3%)
44
11 yrs 54.9%
(47.0%, 62.2%)
31
at 138 mo 54.9%
(47.0%, 62.2%)
24

 

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 176
Leads Currently Active in Study 40
Device Events 21
Cumulative Months of Follow-up 4,250
Model 3887 Pisces-Quad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 9
Lead fracture 7
Device stimulation issue 2
Lead high impedance 2
Device lead damage 1
Total Lead Events 21
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 91.2%
(74.8%, 97.1%)
46
2 yrs 81.0%
(66.2%, 89.8%)
47
3 yrs 77.4%
(62.5%, 87.0%)
48
4 yrs 75.9%
(61.1%, 85.7%)
42
5 yrs 73.9%
(59.0%, 84.1%)
36
6 yrs 71.5%
(56.3%, 82.2%)
29
7 yrs 69.0%
(53.5%, 80.2%)
21
at 87 mo 69.0%
(53.5%, 80.2%)
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 408
Leads Currently Active in Study 69
Device Events 29
Cumulative Months of Follow-up 7,362
Model 3888 Pisces-Quad: Event Summary Table/strong>
Lead Event Total
Lead migration/dislodgment 24
Device stimulation issue 2
Lead high impedance 2
Lead fracture 1
Total Lead Events 29
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.5%
(87.8%, 95.5%)
132
2 yrs 91.0%
(85.7%, 94.4%)
79
3 yrs 85.5%
(77.4%, 90.8%)
63
4 yrs 81.5%
(72.3%, 87.8%)
51
5 yrs 78.3%
(68.2%, 85.5%)
44
6 yrs 74.2%
(62.9%, 82.6%)
34
7 yrs 74.2%
(62.9%, 82.6%)
24
8 yrs 74.2%
(62.9%, 82.6%)
22
9 yrs 74.2%
(62.9%, 82.6%)
21

 

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 137
Leads Currently Active in Study 15
Device Events 10
Cumulative Months of Follow-up 2,885
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 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

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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 119
Leads Currently Active in Study 8
Device Events 30
Cumulative Months of Follow-up 2,217
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 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

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Lead Characteristics
Model Number 3776
FDA Approval Date Nov 2005
Leads Enrolled 183
Leads Currently Active in Study 44
Device Events 13
Cumulative Months of Follow-up 3,427
Model 3776 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 9
Lead high impedance 2
Device stimulation issue 1
Lead fracture 1
Total Lead Events 13
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 92.3%
(86.2%, 95.8%)
79
2 yrs 92.3%
(86.2%, 95.8%)
53
3 yrs 92.3%
(86.2%, 95.8%)
33
4 yrs 89.4%
(79.5%, 94.7%)
22
at 51 mo 89.4%
(79.5%, 94.7%)
22

 

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 792
Leads Currently Active in Study 187
Device Events 53
Cumulative Months of Follow-up 15,645
Model 3777 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 35
Device stimulation issue 7
Lead high impedance 5
Device lead damage 2
Lead fracture 2
Lead low impedance 2
Total Lead Events 53
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 93.5%
(90.9%, 95.4%)
387
2 yrs 89.7%
(86.3%, 92.3%)
233
3 yrs 89.7%
(86.3%, 92.3%)
147
4 yrs 89.0%
(85.3%, 91.9%)
86
5 yrs 87.9%
(83.3%, 91.3%)
61
6 yrs 84.7%
(78.0%, 89.6%)
48
7 yrs 84.7%
(78.0%, 89.6%)
32
8 yrs 77.7%
(64.6%, 86.4%)
21
9 yrs 70.3%
(54.1%, 81.7%)
21
at 111 mo 70.3%
(54.1%, 81.7%)
21

 

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 2,121
Leads Currently Active in Study 558
Device Events 245
Cumulative Months of Follow-up 44,764
Model 3778 Pisces-Octad: Event Summary Table
Lead Event Total
Lead migration/dislodgment 187
Lead high impedance 31
Lead fracture 14
Device stimulation issue 6
Medical device complicationa 4
Device malfunctionb 2
Lead low impedance 1
Total Lead Events 245

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 89.8%
(88.2%, 91.2%)
1,167
2 yrs 86.4%
(84.5%, 88.1%)
676
3 yrs 84.1%
(81.9%, 86.1%)
429
4 yrs 83.6%
(81.2%, 85.7%)
268
5 yrs 80.9%
(77.8%, 83.7%)
173
6 yrs 79.1%
(75.3%, 82.4%)
107
7 yrs 76.4%
(71.5%, 80.6%)
42
at 93 mo 76.4%
(71.5%, 80.6%)
23

 

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 98
Leads Currently Active in Study 37
Device Events 17
Cumulative Months of Follow-up 2,658
Model 3986A Resume TL: Event Summary Table
Lead Event Total
Lead high impedance 9
Device connection issue 2
Device stimulation issue 2
Lead low impedance 2
Lead migration/dislodgment 2
Total Lead Events 17
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 84.9%
(73.8%, 91.6%)
46
2 yrs 84.9%
(73.8%, 91.6%)
36
3 yrs 82.6%
(70.5%, 90.1%)
25
4 yrs 82.6%
(70.5%, 90.1%)
22
at 51 mo 82.6%
(70.5%, 90.1%)
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 148
Leads Currently Active in Study 24
Device Events 10
Cumulative Months of Follow-up 2,798
Model 3998 Specify: Event Summary Table
Lead Event Total
Lead high impedance 4
Lead fracture 3
Lead migration/dislodgment 2
Device stimulation issue 1
Total Lead Events 10
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 96.9%
(88.3%, 99.2%)
57
2 yrs 91.2%
(79.9%, 96.3%)
38
at 33 mo 87.9%
(74.0%, 94.6%)
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 236
Leads Currently Active in Study 132
Device Events 7
Cumulative Months of Follow-up 3,290
Model 39565 Specify: Event Summary Table
Lead Event Total
Lead migration/dislodgment 7
Total Lead Events 7
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 96.9%
(92.8%, 98.7%)
94
2 yrs 96.9%
(92.8%, 98.7%)
53
3 yrs 96.9%
(92.8%, 98.7%)
25
at 39 mo 96.9%
(92.8%, 98.7%)
22

 

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

Lead Characteristics
Model Number 977A1
FDA Approval Date Mar 2013
Leads Enrolled 83
Leads Currently Active in Study 66
Device Events 2
Cumulative Months of Follow-up 437
Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Event Summary Table
Lead Event Total
Device component issue 2
Total Lead Events 2
Time Interval Survival
(95% Confidence Interval)
Sample Size
at 6 mo 94.7%
(80.6%, 98.7%)
31
at 9 mo 94.7%
(80.6%, 98.7%)
21

 

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

View Larger Image

Lead Characteristics
Model Number 977A2
FDA Approval Date Mar 2013
Leads Enrolled 1,330
Leads Currently Active in Study 1,152
Device Events 37
Cumulative Months of Follow-up 7,073
Model 977A2 Vectris SureScan MRI 1x8 Compact: Event Summary Table
Lead Event Total
Lead migration/dislodgment 27
Lead high impedance 5
Lead fracture 4
Lead low impedance 1
Total Lead Events 37
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 95.7%
(93.7%, 97.0%)
225
at 21 mo 92.9%
(88.8%, 95.5%)
20

 

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

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 937 331 162 26,143
3887 Pisces-Quad Jan 1997 176 40 21 4,250
3888 Pisces-Quad Nov 1992 408 69 29 7,362
3890 Pisces-Quad LZ Sep 2002 137 15 10 2,885
3891 Pisces-Quad LZ Sep 2002 119 8 30 2,217
3776 Pisces-Octad Nov 2005 183 44 13 3,427
3777 Pisces-Octad Apr 2005 792 187 53 15,645
3778 Pisces-Octad Apr 2005 2,121 558 245 44,764
977A1 Vectris SureScan Mar 2013 83 66 2 437
977A2 Vectris SureScan Mar 2013 1,330 1,152 37 7,073
Surgical Leads
3986A Resume TL Apr 1995b 98 37 17 2,658
3998 Specify Feb 1998 148 24 10 2,798
39565 Specify Jun 2007 236 132 7 3,290

a There were a total of 748 lead-related events reported to the registry, but only 636 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=3), or were subsequent or unlinked device events that did not affect the survival estimates.
b Model 977A1 had a device survival probability of 93.8 % (77.3%, 98.4%) at 6 months of follow-up.
c 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 90.1%
(87.2%, 92.4%)
87.0%
(83.8%, 89.7%)
79.9%
(75.8%, 83.3%)
73.1%
(68.5%, 77.2%)
3887 Pisces-Quad 91.2%
(74.8%, 97.1%)
81.0%
(66.2%, 89.8%)
77.4%
(62.5%, 87.0%)
75.9%
(61.1%, 85.7%)
3888 Pisces-Quad 92.5%
(87.8%, 95.5%)
91.0%
(85.7%, 94.4%)
85.5%
(77.4%, 90.8%)
81.5%
(72.3%, 87.8%)
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 92.3%
(86.2%, 95.8%)
92.3%
(86.2%, 95.8%)
92.3%
(86.2%, 95.8%)
89.4%
(79.5%, 94.7%)
3777 Pisces-Octad 93.5%
(90.9%, 95.4%)
89.7%
(86.3%, 92.3%)
89.7%
(86.3%, 92.3%)
89.0%
(85.3%, 91.9%)
3778 Pisces-Octad 89.8%
(88.2%, 91.2%)
86.4%
(84.5%, 88.1%)
84.1%
(81.9%, 86.1%)
83.6%
(81.2%, 85.7%)
977A1 Vectris SureScan b - - -
977A2 Vectris SureScan 95.7%
(93.7%, 97.0%)
- - -
Surgical Leads
3986A Resume TL 84.9%
(73.8%, 91.6%)
84.9%
(73.8%, 91.6%)
82.6%
(70.5%, 90.1%)
82.6%
(70.5%, 90.1%)
3998 Specify 96.9%
(88.3%, 99.2%)
91.2%
(79.9%, 96.3%)
- -
39565 Specify 96.9%
(92.8%, 98.7%)
96.9%
(92.8%, 98.7%)
96.9%
(92.8%, 98.7%)
-

a There were a total of 748 lead-related events reported to the registry, but only 636 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=3), or were subsequent or unlinked device events that did not affect the survival estimates.
b Model 977A1 had a device survival probability of 93.8 % (77.3%, 98.4%) at 6 months of follow-up.
c FDA clearance date.

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%
(65.4%, 74.7%)
65.8%
(60.3%, 70.7%)
63.4%
(57.6%, 68.7%)
63.4%
(57.6%, 68.7%)
3887 Pisces-Quad 73.9%
(59.0%, 84.1%)
71.5%
(56.3%, 82.2%)
69.0%
(53.5%, 80.2%)
-
3888 Pisces-Quad 78.3%
(68.2%, 85.5%)
74.2%
(62.9%, 82.6%)
74.2%
(62.9%, 82.6%)
74.2%
(62.9%, 82.6%)
3890 Pisces-Quad LZ 83.8%
(68.8%, 92.0%)
- - -
3891 Pisces-Quad LZ - - - -
3776 Pisces-Octad - - - -
3777 Pisces-Octad 87.9%
(83.3%, 91.3%)
84.7%
(78.0%, 89.6%)
84.7%
(78.0%, 89.6%)
77.7%
(64.6%, 86.4%)
3778 Pisces-Octad 80.9%
(77.8%, 83.7%)
79.1%
(75.3%, 82.4%)
76.4%
(71.5%, 80.6%)
-
977A1 Vectris SureScan - - - -
977A2 Vectris SureScan - - - -
Surgical Leads
3986A Resume TL - - - -
3998 Specify - - - -
39565 Specify - - - -

a There were a total of 748 lead-related events reported to the registry, but only 636 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=3), or were subsequent or unlinked device events that did not affect the survival estimates.
b Model 977A1 had a device survival probability of 93.8 % (77.3%, 98.4%) at 6 months of follow-up.
c FDA clearance date.

 

Device Survival Probability (95% Confidence Interval)Table 3 of 3
Model
Number
Family 9 yrs 10 yrs 11 yrs
Percutaneous Leads
3487A Pisces-Quad 61.3%
(55.0%, 67.1%)
56.5%
(48.9%, 63.3%)
54.9%
(47.0%, 62.2%)
3887 Pisces-Quad - - -
3888 Pisces-Quad 74.2%
(62.9%, 82.6%)
- -
3890 Pisces-Quad LZ - - -
3891 Pisces-Quad LZ - - -
3776 Pisces-Octad - - -
3777 Pisces-Octad 70.3%
(54.1%, 81.7%)
- -
3778 Pisces-Octad - - -
977A1 Vectris SureScan - - -
977A2 Vectris SureScan - - -
Surgical Leads
3986A Resume TL - - -
3998 Specify - - -
39565 Specify - - -

a There were a total of 748 lead-related events reported to the registry, but only 636 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=3), or were subsequent or unlinked device events that did not affect the survival estimates.
b Model 977A1 had a device survival probability of 93.8 % (77.3%, 98.4%) at 6 months of follow-up.
c FDA clearance date.

Extensions

From June 2004 to the report cut-off date of July 31, 2015, there were 3,093 extensions followed in the registry. Differences between the total number of extensions versus spinal cord stimulators (N=4,176) were due to the fact that some systems did not use an extension. The aggregate prospective follow-up time for all extensions was 70,468 months (5,872 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 1,256 (40.6%)
7489 731 (23.6%)
37082 596 (19.3%)
7495 252 (8.1%)
37083 209 (6.8%)
7472 20 (0.6%)
7496 9 (0.3%)
7471 8 (0.3%)
Other/Unspecified 12 (0.4%)
Total 3,093 (100%)

Extension EventsExtension Events

There were 22 product performance-related events with an underlying reported etiology related to the extension. This includes 18 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=14). Of the 22 events, 18 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:

  • 18 had follow-up time cut-off due to product performance-related events
  • 2,290 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.
  • 785 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 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 731
Extensions Currently Active in Study 81
Device Events 4
Cumulative Months of Follow-up 16,903
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%)
204
4 yrs 98.3% 
(95.6%, 99.4%)
136
5 yrs 98.3% 
(95.6%, 99.4%)
103
6 yrs 98.3% 
(95.6%, 99.4%)
78
7 yrs 98.3% 
(95.6%, 99.4%)
59
8 yrs 98.3% 
(95.6%, 99.4%)
59
9 yrs 98.3% 
(95.6%, 99.4%)
55
10 yrs 98.3% 
(95.6%, 99.4%)
40
at 126 mo 98.3% 
(95.6%, 99.4%)
24

 

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 1,256
Extensions Currently Active in Study 413
Device Events 6
Cumulative Months of Follow-up 24,785
Model 37081 Extension: Event Summary Table
Extension Event Total
Extension fracture 5
Extension migration 1
Total Extension Events 6
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.9%
(99.2%, 100.0%)
653
2 yrs 99.3%
(98.1%, 99.7%)
374
3 yrs 98.7%
(96.9%, 99.4%)
204
4 yrs 98.7%
(96.9%, 99.4%)
141
5 yrs 98.7%
(96.9%, 99.4%)
98
6 yrs 98.7%
(96.9%, 99.4%)
65
7 yrs 98.7%
(96.9%, 99.4%)
36
at 90 mo 98.7%
(96.9%, 99.4%)
28

 

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 596
Extensions Currently Active in Study 182
Device Events 3
Cumulative Months of Follow-up 16,397
Model 37082 Extension: Event Summary Table
Extension Event Total
Extension fracture 2
Paraesthesiaa 1
Total Extension Events 3

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%)
393
2 yrs 99.3%
(97.9%, 99.8%)
254
3 yrs 99.3%
(97.9%, 99.8%)
160
4 yrs 99.3%
(97.9%, 99.8%)
107
5 yrs 99.3%
(97.9%, 99.8%)
85
6 yrs 99.3%
(97.9%, 99.8%)
60
7 yrs 99.3%
(97.9%, 99.8%)
38
at 93 mo 99.3%
(97.9%, 99.8%)
22

 

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 209
Extensions Currently Active in Study 45
Device Events 4
Cumulative Months of Follow-up 5,315
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%
(93.9%, 99.9%)
119
2 yrs 97.3%
(91.8%, 99.1%)
96
3 yrs 96.1%
(89.8%, 98.5%)
56
4 yrs 96.1%
(89.8%, 98.5%)
44
5 yrs 96.1%
(89.8%, 98.5%)
31
6 yrs 96.1%
(89.8%, 98.5%)
25
at 81 mo 96.1%
(89.8%, 98.5%)
20

 

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
1,256 413 6 24,785
37082 37082 Mar
2006
596 182 3 16,397
37083 37083 Sep
2005
209 45 4 5,315
7489 7489 Oct
2002
731 81 4 16,903

a There were a total of 22 extension-related events reported to the registry, but only 17 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=1), or were subsequent 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%
(99.2%, 100.0%)
99.3%
(98.1%, 99.7%)
98.7%
(96.9%, 99.4%)
98.7%
(96.9%, 99.4%)
98.7%
(96.9%, 99.4%)
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%
(93.9%, 99.9%)
97.3%
(91.8%, 99.1%)
96.1%
(89.8%, 98.5%)
96.1%
(89.8%, 98.5%)
96.1%
(89.8%, 98.5%)
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
37081 98.7%
(96.9%, 99.4%)
98.7%
(96.9%, 99.4%)
- - -
37082 99.3%
(97.9%, 99.8%)
99.3%
(97.9%, 99.8%)
- - -
37083 96.1%
(89.8%, 98.5%)
- - - -
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%)

2015 Medtronic Product Performance Report: Data through July 31, 2015

United States