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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 the date of initiation of the Implantable Systems Performance Registry (ISPR) for spinal cord stimulation systems in June 2004 and the report cut-off date of July 31, 2013. Forty-four centers enrolled and contributed patients to the spinal cord stimulation section of the report.


Patients

Of the 2,472 total spinal cord stimulation patients enrolled in the ISPR, 45.6% were implanted for the treatment of other pain indications, 42.8% were implanted for the treatment of failed back pain, 11.3% were implanted for the treatment of complex regional pain syndrome (CRPS), and 0.4% 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 1,126 (45.6%)
Radicular pain syndrome 318 (12.9%)
Degenerative disc disease 79 (3.2%)
Cervical pain 12 (0.5%)
Diabetic neuropathy 5 (0.2%)
Post Herpetic Neuralgia 5 (0.2%)
Traumatic nerve injury 5 (0.2%)
Facial pain 3 (0.1%)
Epidural Fibrosis 2 (0.1%)
Post herniorrhaphy pain 1 (0.1%)
Other chronic pain 605 (24.5%)
Other 91 (3.7%)
Failed Back Pain 1,058 (42.8%)
Postlaminectomy pain 495 (20.0%)
Failed Back Syndrome (FBS) 351 (14.2%)
Combination back and leg pain 121 (4.9%)
Multiple Back Operations 64 (2.6%)
Arachnoiditis 21 (0.8%)
Unsuccessful Disc Surgery 6 (0.2%)
CRPS 279 (11.3%)
CRPS I 213 (8.6%)
CRPS II 66 (2.7%)
Not Specified 9 (0.4%)
Total Patients 2,472

a Refer to product labeling for approved indications.

 

Event Summary

There were 1,696 events reported between June 2004 and July 31, 2013 in patients with spinal cord stimulation systems. Thirty-five percent of these events (597/1,696) were categorized as product performance-related and are presented graphically within this report. The 597 product performance events occurred in 278 of the 2,472 total patients (11.2%) enrolled. In addition, there were 1,024 non-product performance events and 75 deaths, none of which were reported as a direct result of a device-related event or the stimulation therapy during this timeframe. 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=2,472)
Lead migration/dislodgment 316 164 6.63%
High impedance 80 36 1.46%
Lead fracture 46 31 1.25%
Undesirable change in stimulationc 45 25 1.01%
Medical device complicationd 38 21 0.85%
Low impedance 17 5 0.20%
Device malfunctione 14 7 0.28%
Recharging unable to rechargef 14 14 0.57%g
Extension fracture 13 8 0.32%
Device failureh 6 5 0.20%
Impedance NOS 3 3 0.12%
Paraesthesia 2 2 0.08%
Therapeutic productive ineffective 2 1 0.04%
Broken bond wire 1 1 0.04%
Total 597 278 11.25%

a MedDRA Preferred Term
b The total number of patients may not represent the sum of all rows, as a patient may have experienced more than one type of event
c Undesirable change in stimulation reported by the physician as being caused by the neurostimulator (n=2) or lead (n=43)
d Includes 6 events reported as electrodes out of range, 4 leads no longer provided stimulation, 3 error messages on patient programmer, 2 broken recharging units, 2 events reported as damaged leads, 2 damaged electrodes, 2 lead electrodes not functional, 2 lead malfunction secondary to open circuit, 2 events reported as unable to pass stylet into lead, 2 lead failures, 2 broken recharge belts, 1 lead with pinched outer insulation, 1 separation of the material on the end of the neuroelectrode, 1 broken recharger strap, 1 broken antenna cord, 1 broken patient programmer, 1 neurostimulator losing charge, 1 faulty antenna, 1 lead damaged contacts, and 1 unknown problem with an extension
e Includes 8 events reported as electrodes out of range too high, 2 event for impedance not measureable, 2 neurostimulator malfunctions, 1 increased lead impedance, and 1 antenna malfunction
f Patient was unable to recharge due to device related issue (includes issues with external devices)
g There were a total of 1480 patients that used rechargeable SCS neurostimulators in the ISPR. A total of 0.9% (14/1480) of patients with a rechargeable SCS neurostimulator experienced a recharging unable to recharge event
h Includes 1 broken jack and antenna, 1 failure of lead electrodes, 1 extension failure, 1 defective patient programmer, 1 frayed wire to recharger, and 1 broken antenna

A total of 539 (90.3%) of the 597 product performance events were related to the lead, 21 (3.5%) were related to an external device, 16 (2.7%) were related to the extension, 10 (1.7%) were related to the stimulator, 2 (0.3%) were related to programming/stimulation, 6 (1.0%) were related to recharging process, 1 (0.2%) was related to both the stimulator and the lead, 1 (0.2%) was related to incisional site/device tract, and 1 (0.2%) was related to other etiology. Relatedness is determined by the physician.

Product Performance Events by Etiology

Product Performance Events by Etiology Chart

 
Neurostimulation System Non-Product Performance Events (including adverse eventsa and device events, excluding deaths)
Eventsb Number of Non-Product Performance Events
Neurostimulator battery depletion 310
Implant site pain 108
Undesirable change in stimulationc 70
Therapeutic product ineffective 67
Recharging unable to recharged 62
Therapy non-responder 60
Implant site infection 58
Change in sensation of stimulationc 40
Pain 29
Neurostimulator migration 27
Paraesthesia 20
Implant site erosion 14
Implant site erythema 14
Medical device complicatione 13
Implant site effusion 9
Incision site complication 8
Infection 8
Wound dehiscence 7
Pain in extremity 6
Back pain 5
Otherf 89
Total 1,024

a Adverse events associated with product performance events are not included in this table
b MedDRA Preferred Term
c Event reported by the physician with an etiology that was not device related
d Patient was unable to recharge due to an issue not related to the device
e Includes 4 events reported as inability to activate neurostimulation not due to neurostimulator, 1 'POR' alarm noted on patient's programmer that resolved after POR, 1 prominent protrusion of the neuroelectrodes and bifurcated connectors in the left flank, 1 lead tip protruding against the skin, 1 patient unable to work neurostimulator, 1 battery depletes too quickly not due to a device issue, 1 inability to interrogate the pulse generator due to patient usability issues, 1 punctured IPG wall during surgery, 1 spinal cord stimulator not working due to patient difficulties turning device on and off, 1 protruding generator
f Composed of 58 event codes that include fewer than 5 patients each and one event that had not been MedDRA coded at the time of the report cut-off

There were 75 deaths reported in the ISPR 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, 50.7% of patient deaths occurred in patients receiving therapy for pain indications in the unspecified "other" category, 42.7% for failed back, and 6.7% for CRPS.

Death by Primary Indication
Primary Indication N (%)
CRPS 5 (6.67%)
Failed Back 32 (42.67%)
Other 38 (50.67%)
Total 75 (100%)

Spinal Cord Stimulators

From June 2004 to the report cut-off date of July 31, 2013, 2,841 spinal cord stimulators were followed in the Implantable Systems Performance Registry (ISPR). The difference between the total number of patients (n=2,472) versus spinal cord stimulators is due to the fact that some patients had multiple spinal cord stimulators or were subsequently re-implanted.

Twenty-one percent (21.0%) of the spinal cord stimulators were PrimeAdvanced, 19.6% were RestoreUltra, 16.2% were Synergy, 15.7% were Restore, 12.1% were RestoreAdvanced, 7.7% were RestoreSensor, 3.6% were Itrel 3, and a smaller number were RestorePrime (2.0%), Synergy Versitrel (1.3%), SynergyPlus+ (0.8%), and there was 1 other unspecified model. The aggregate prospective follow-up time for all spinal cord stimulators was 56,536 months (4,711 years).

Spinal Cord Stimulator Events Spinal Cord Stimulator Events

There were 11 product performance-related events with an underlying reported etiology related to spinal cord stimulator function. Of these, 9 were the first event attributable to an enrolled stimulator. For spinal cord stimulators in the ISPR, the current return rate to Medtronic Returned Product Analysis (RPA) was 179/720 (25%). The proportion was based upon the number of ISPR 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 11 spinal cord stimulator events was confirmed by Medtronic RPA as a broken bond wire. The remaining 10 spinal cord stimulators with performance-related events were not returned to Medtronic RPA but were assigned as device related by the physician as medical device complication (n=3), device malfunction (n=2), undesirable change in stimulation (n=2), high impedance (n=1), paraesthesia (n=1), or recharging unable to recharge (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. A total of 9 stimulators had follow-up time cut-off due to product performance-related events. There were 1,819 spinal cord stimulators censored in the survival analysis for the following reasons: patient expired, stimulator explanted, site termination, patient discontinued, patient lost to follow-up, other stimulator modification, therapy suspended, or non-product performance stimulator-related event without an associated intervention. The remaining 1,013 spinal cord stimulators, which 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. Survival curves are only shown if more than 20 devices had at least 24 months of follow-up at the time of the report cut-off for each model. Currently, the 95% confidence intervals for all neurostimulator models overlap, indicating that survival from neurostimulator-related events is not significantly different between the neurostimulator models across various applicable follow-up time points.

             

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 102
Neurostimulators Currently Active in Study 1
Device Events 0
Cumulative Months of Follow-up 2,039
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
1 yr 100.0% 59
2 yrs 100.0% 44
3 yrs 100.0% 26
at 39 mo 100.0% 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 459
Neurostimulators Currently Active in Study 21
Device Events 2
Cumulative Months of Follow-up 10,878
Neurostimulator Event Total
Undesirable change in stimulation 1
Broken bond wire 1
Total Neurostimulator Events 2
Time Interval Survival Effective Sample Size
1 yr 100.0% 270
2 yrs 100.0% 215
3 yrs 100.0% 143
4 yrs 99.2% 88
5 yrs 97.9% 47
6 yrs 97.9% 31
7 yrs 97.9% 21
at 87 mo 97.9% 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 38
Neurostimulators Currently Active in Study 1
Device Events 0
Cumulative Months of Follow-up 737
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
1 yr 100.0% 21
at 15 mo 100.0% 20

 

Model 7427V Synergy Versitrel: Specifications

Height 2.4 in (61 mm) ppr-7427V
Width 2.4 in (61 mm)
Thinness 0.6 in (15 mm)
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 8
Device Events 0
Cumulative Months of Follow-up 1,353
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
1 yr 100.0% 43
2 yrs 100.0% 25
at 30 mo 100.0% 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 596
Neurostimulators Currently Active in Study 195
Device Events 1
Cumulative Months of Follow-up 8,070
Neurostimulator Event Total
Undesirable change in stimulation 1
Total Neurostimulator Events 1
Time Interval Survival Effective Sample Size
1 yr 99.7% 293
2 yrs 99.7% 130
3 yrs 99.7% 47
4 yrs 99.7% 20

 

Model 37702 PrimeAdvanced: Specifications

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

Model 37711 Restore: Survival from Spinal Cord Stimulator Events

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

Model 37711 Restore: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name Restore
FDA Approval Date Apr 2005
Neurostimulators Enrolled 447
Neurostimulators Currently Active in Study 61
Device Events 2
Cumulative Months of Follow-up 12,798
Neurostimulator Event Total
Paraesthesia 1
Recharging unable to recharge 1
Total Neurostimulator Events 2
Time Interval Survival Effective Sample Size
1 yr 100.0% 318
2 yrs 100.0% 231
3 yrs 100.0% 147
4 yrs 100.0% 90
5 yrs 100.0% 69
6 yrs 96.5% 46
7 yrs 96.5% 23

 

Model 37711 Restore: Specifications

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

Model 37713 RestoreAdvanced: Survival from Spinal Cord Stimulator Events

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

Model 37713 RestoreAdvanced: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name RestoreAdvanced
FDA Approval Date Jul 2006
Neurostimulators Enrolled 343
Neurostimulators Currently Active in Study 142
Device Events 0
Cumulative Months of Follow-up 7,017
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
1 yr 100.0% 196
2 yrs 100.0% 121
3 yrs 100.0% 76
4 yrs 100.0% 44
5 yrs 100.0% 32
at 66 mo 100.0% 22

 

Model 37713 RestoreAdvanced: Specifications

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

Model 37712 RestoreUltra: Survival from Spinal Cord Stimulator Events

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

Model 37712 RestoreUltra: Survival from Spinal Cord Stimulator Events

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Spinal Cord Stimulator Characteristics
Model Name RestoreUltra
FDA Approval Date Jan 2008
Neurostimulators Enrolled 556
Neurostimulators Currently Active in Study 179
Device Events 4
Cumulative Months of Follow-up 9,958
Neurostimulator Event Total
Device malfunctiona 2
High impedance 1
Medical device complicationb 1
Total Neurostimulator Events 4

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

Time Interval Survival Effective Sample Size
1 yr 99.8% 324
2 yrs 98.7% 173
3 yrs 98.7% 99
4 yrs 96.5% 45
at 54 mo 96.5% 24

 

Model 37712 RestoreUltra: Specifications

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

Model 37714 RestoreSensor: Survival from Spinal Cord Stimulator Events

Spinal Cord Stimulator Characteristics
Model Name RestoreSensor
FDA Approval Date Nov 2011
Neurostimulators Enrolled 218
Neurostimulators Currently Active in Study 201
Device Events 0
Cumulative Months of Follow-up 953
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
6 mo 100.0% 90
1 yr 100.0% 37

 

Model 37714 RestoreSensor: Specifications

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

Spinal Cord Stimulator Survival Summary Spinal Cord Stimulator Survival Summary

Currently, survival from neurostimulator-related events is not statistically significantly different between the neurostimulator models across all applicable follow-up time points.

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
102 1 0 2,039
Synergy Synergy Nov
1999
459 21 2 10,878
Synergy
Versitrel
Synergy Dec
2001
38 1 0 737
Restore
Prime
Restore Mar
2006
57 8 0 1,353
Prime
Advanced
Prime
Advanced
Jul
2006
596 195 1 8,070
Rechargeable Neurostimulators
Restore Restore Apr
2005
447 61 2 12,798
Restore
Advanced
Restore Jul
2006
343 142 0 7,017
Restore
Ultra
Restore Jan
2008
556 179 4 9,958
Restore
Sensor
Restore Nov
2011
218 201 0 953

a There were 11 neurostimulator-related events reported to the ISPR, but only 9 events included in this summary table. The remaining neurostimulator-related events were subsequent events that did not affect the device survival estimates.

Device Survival Probability (95% Confidence Interval)Table 1 of 2
Model Name 1 yr 2 yrs 3 yrs 4 yrs
Primary Cell Neurostimulators
Itrel 3 100.0%
NA
100.0%
NA
100.0%
NA
-
Synergy 100.0%
NA
100.0%
NA
100.0%
NA
99.2%
(97.7%, 100.0%)
Synergy Versitrel 100.0%
NA
- - -
RestorePrime 100.0%
NA
100.0%
NA
- -
PrimeAdvanced 99.7%
(99.1%, 100.0%)
99.7%
(99.1%, 100.0%)
99.7%
(99.1%, 100.0%)
99.7%
(99.1%, 100.0%)
Rechargeable Neurostimulators
Restore 100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
RestoreAdvanced 100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
RestoreUltra 99.8%
(99.4%, 100.0%)
98.7%
(97.2%, 100.0%)
98.7%
(97.2%, 100.0%)
96.5%
(91.9%, 100.0%)
RestoreSensor 100.0%
NA
- - -
Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Name 5 yrs 6 yrs 7 yrs
Primary Cell Neurostimulators
Itrel 3 - - -
Synergy 97.9%
(95.0%, 100.0%)
97.9%
(95.0%, 100.0%)
97.9%
(95.0%, 100.0%)
Synergy Versitrel - - -
RestorePrime - - -
PrimeAdvanced - - -
Rechargeable Neurostimulators
Restore 100.0%
NA
96.5%
(91.5%, 100.0%)
96.5%
(91.5%, 100.0%)
RestoreAdvanced 100.0%
NA
- -
RestoreUltra - - -
RestoreSensor - - -

Leads

From June 2004 to the report cut-off date of July 31, 2013, there were 4,963 leads followed in the Implantable Systems Performance Registry (ISPR). Differences between the total number of leads versus spinal cord stimulators (n=2,841) were due to the fact that some patients were subsequently re-implanted with a new lead or were implanted with more than 1 lead.

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). Nearly ninety percent (89.7%) of leads in the ISPR were percutaneous leads (4,452/4,963) including 57.4% (2,849/4,963) in the Pisces-Octad lead family, 27.4% (1,361/4,963) in the Pisces-Quad lead family, and 4.9% (242/4,963) in the Pisces-Quad LZ lead family. Nine percent (9.2%) of leads (458/4,963) were surgical leads. A small number of leads (53/4,963) were designated as Other (1.1%). The aggregate prospective follow-up time for all leads was 108,193 months (9,016 years).

Lead EventsLead Events

There were 540 product performance-related events with an underlying reported etiology related to the lead. Of these events, the majority were lead migration/dislodgements (n=314), high impedance (n=78), lead fracture (n=46), undesirable change in stimulation (n=43), medical device complication (n=25), low impedance (n=17), device malfunction (n=11), impedance NOS (n=3), therapeutic product ineffective (n=2), or device failure (n=1). Of the 540 events, 473 were the first event attributable to an enrolled lead. There were 445 events in 4,452 (10.0%) percutaneous leads, 25 events in 458 (5.5%) surgical leads, and 3 events occurred in leads with unknown model numbers.

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. A total of 473 leads had follow-up time cut-off due to product performance-related events. There were 2,469 leads censored in the survival analysis for the following reasons: patient expired, lead explanted, site termination, patient discontinued, patient lost to follow-up, other lead modification, therapy suspended, or non-product performance lead-related event without an associated intervention. The remaining 2,021 leads, which were free from product performance-related events and censoring events, were censored at the last follow-up prior to the report cut-off.

Lead SurvivalLead Survival

The figures and tables below represent lead survival and 95% confidence intervals where at least 20 leads contributed to each 3-month interval. For surgical leads, at 3 years of follow-up the 95% confidence interval for lead Model 3986A does not overlap with Model 39565 indicating that Model 39565 is currently performing better at this time point.

For percutaneous leads, the 95% confidence interval for Pisces-Quad LZ Model 3891 leads does not overlap with several of the other percutaneous lead models at 1 and 2 years of follow-up. 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. In addition, Model 3776 has consistently high device survival probability at 1 through 3 years when compared to several other percutaneous lead models.

         
   

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 839
Leads Currently Active in Study 358
Device Events 122
Cumulative Months of Follow-up 23,242
Lead Event Total
High impedance 37
Lead migration/dislodgment 31
Undesirable change in stimulation 17
Low impedance 12
Lead fracture 10
Device malfunctiona 8
Medical device complicationb 5
Impedance NOS 2
Total Lead Events 122

a Reported as electrodes out of range
b 3 events were reported as electrodes out of range, 1 event as lead with pinched outer insulation, 1 as separation of the material on the end of the neuroelectrode

Time Interval Survival Effective Sample Size
1 yr 90.1% 430
2 yrs 87.2% 342
3 yrs 81.8% 271
4 yrs 76.6% 197
5 yrs 72.8% 146
6 yrs 68.7% 114
7 yrs 66.0% 79
8 yrs 66.0% 57
9 yrs 66.0% 42
10 yrs 62.3% 35
11 yrs 59.8% 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 151
Leads Currently Active in Study 28
Device Events 14
Cumulative Months of Follow-up 4,690
Lead Event Total
Lead fracture 7
Lead migration/dislodgment 3
Undesirable change in stimulation 2
High impedance 1
Medical device complicationa 1
Total Lead Events 14

a Reported as lead damaged contacts

Time Interval Survival Effective Sample Size
1 yr 96.8% 72
2 yrs 88.9% 58
3 yrs 85.8% 58
4 yrs 84.0% 43
5 yrs 81.8% 39
6 yrs 79.6% 37
at 81 mo 77.2% 31

 

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 354
Leads Currently Active in Study 74
Device Events 28
Cumulative Months of Follow-up 7,570
Lead Event Total
Lead migration/dislodgment 25
Undesirable change in stimulation 2
Lead fracture 1
Total Lead Events 28
Time Interval Survival Effective Sample Size
1 yr 91.7% 153
2 yrs 90.3% 83
3 yrs 85.5% 72
4 yrs 84.2% 63
5 yrs 81.2% 52
6 yrs 77.1% 36
7 yrs 77.1% 24
at 90 mo 77.1% 24

 

Model 3888 Pisces-Quad: Specifications

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

Model 3890 Pisces-Quad LZ: Survival from Lead Events

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

Model 3890 Pisces-Quad LZ: Survival from Lead Events

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Note: As of February 6, 2008, Medtronic discontinued worldwide distribution of the Pisces Quad LZ lead due to performance relative to other percutaneous leads and minimal commercial demand for the product.
Lead Characteristics
Model Number 3890
FDA Approval Date Sep 2002
Leads Enrolled 128
Leads Currently Active in Study 13
Device Events 10
Cumulative Months of Follow-up 3,123
Lead Event Total
Lead migration/dislodgment 4
Device malfunction 2
High impedance 2
Lead fracture 2
Total Lead Events 10
Time Interval Survival Effective Sample Size
1 yr 100.0% 53
2 yrs 96.9% 65
3 yrs 89.8% 51
4 yrs 89.8% 33
5 yrs 86.5% 25
at 63 mo 82.6% 22

 

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 114
Leads Currently Active in Study 12
Device Events 28
Cumulative Months of Follow-up 2,148
Lead Event Total
Lead migration/dislodgment 16
Lead fracture 6
Undesirable change in stimulation 4
Medical device complicationa 2
Total Lead Events 28

a Two events reported as damaged electrodes

Time Interval Survival Effective Sample Size
1 yr 80.1% 66
2 yrs 77.2% 39
at 33 mo 58.6% 20

 

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 159
Leads Currently Active in Study 62
Device Events 4
Cumulative Months of Follow-up 2,709
Lead Event Total
Lead migration/dislodgement 2
Lead fracture 1
Undesirable change in stimulation 1
Total Lead Events 4
Time Interval Survival Effective Sample Size
1 yr 97.8% 70
2 yrs 97.8% 40
3 yrs 97.8% 31
at 45 mo 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

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Lead Characteristics
Model Number 3777
FDA Approval Date Apr 2005
Leads Enrolled 663
Leads Currently Active in Study 123
Device Events 46
Cumulative Months of Follow-up 13,722
Lead Event Total
Lead migration/dislodgment 33
Undesirable change in stimulation 7
High impedance 3
Medical device complicationa 2
Lead fracture 1
Total Lead Events 46

a Two events reported as damaged leads

Time Interval Survival Effective Sample Size
1 yr 93.6% 399
2 yrs 89.8% 232
3 yrs 89.8% 131
4 yrs 89.8% 77
5 yrs 88.4% 55
6 yrs 84.3% 43
at 81 mo 84.3% 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

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Lead Characteristics
Model Number 3778
FDA Approval Date Apr 2005
Leads Enrolled 2,027
Leads Currently Active in Study 901
Device Events 192
Cumulative Months of Follow-up 32,871
Lead Event Total
Lead migration/dislodgment 158
High impedance 13
Lead fracture 9
Medical device complicationa 6
Undesirable change in stimulation 4
Device malfunctionb 1
Low impedance 1
Total Lead Events 192

a Two events were reported as lead electrodes not functional, 2 as lead malfunction secondary to open circuit, and 2 as open circuit on lead.
b Reported as increased lead impedance

Time Interval Survival Effective Sample Size
1 yr 90.7% 994
2 yrs 86.8% 528
3 yrs 84.0% 329
4 yrs 83.5% 182
5 yrs 81.2% 100
6 yrs 77.4% 37
at 78 mo 77.4% 21

 

Model 3778 Pisces-Octad: Specifications

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

Model 3986A Resume TL: Survival from Lead Events

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

Model 3986A Resume TL: Survival from Lead Events

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Lead Characteristics
Model Number 3986A
FDA Approval Date Apr 1995
Leads Enrolled 91
Leads Currently Active in Study 39
Device Events 10
Cumulative Months of Follow-up 2,156
Lead Event Total
High impedance 5
Low impedance 2
Undesirable change in stimulation 2
Lead migration/dislodgment 1
Total Lead Events 10
Time Interval Survival Effective Sample Size
1 yr 87.3% 49
2 yrs 87.3% 35
3 yrs 84.5% 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 130
Leads Currently Active in Study 13
Device Events 10
Cumulative Months of Follow-up 2,766
Lead Event Total
Lead fracture 3
High impedance 3
Device failurea 1
Impedance NOS 1
Lead migration/dislodgment 1
Undesirable change in stimulation 1
Total Lead Events 10

a Reported as failure of lead electrodes

Time Interval Survival Effective Sample Size
1 yr 97.0% 60
2 yrs 93.3% 42
3 yrs 90.1% 26
at 39 mo 90.1% 22

 

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 123
Leads Currently Active in Study 55
Device Events 2
Cumulative Months of Follow-up 2,106
Lead Event Total
Lead migration/dislodgment 2
Total Lead Events 2
Time Interval Survival Effective Sample Size
1 yr 97.9% 65
2 yrs 97.9% 41
3 yrs 97.9% 21

 

Model 39565 Specify: Specifications

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

Model 3999 2x4 Hinged: Survival from Lead Events

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

Model 3999 2x4 Hinged: Survival from Lead Events

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Lead Characteristics
Model Number 3999
FDA Approval Date Jun 2004
Leads Enrolled 51
Leads Currently Active in Study 1
Device Events 2
Cumulative Months of Follow-up 1,017
Lead Event Total
Lead migration/dislodgment 2
Total Lead Events 2
Time Interval Survival Effective Sample Size
1 yr 96.7% 37
2 yrs 93.6% 25
at 27 mo 93.6% 22

 

Model 3999 2x4 Hinged: Specifications

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

Lead Survival SummaryLead Survival Summary

For surgical leads, at 3 years of follow-up the 95% confidence interval for lead Model 3986A does not overlap with Model 39565 indicating that Model 39565 is currently performing better at this time point.

For percutaneous leads, the 95% confidence interval for Pisces-Quad LZ Model 3891 leads does not overlap with several of the other percutaneous lead models at 1 and 2 years of follow-up. 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. In addition, Model 3776 has consistently high device survival probability at 1 through 3 years when compared to several other percutaneous lead models.

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 839 358 122 23,242
3887 Pisces-Quad Jan 1997 151 28 14 4,690
3888 Pisces-Quad Nov 1992 354 74 28 7,570
3890 Pisces-Quad LZ Sep 2002 128 13 10 3,123
3891 Pisces-Quad LZ Sep 2002 114 12 28 2,148
3776 Pisces-Octad Nov 2005 159 62 4 2,709
3777 Pisces-Octad Apr 2005 663 123 46 13,722
3778 Pisces-Octad Apr 2005 2,027 901 192 32,871
Surgical Leads
3986A Resume TL Apr 1995 91 39 10 2,156
3998 Specify Feb 1998 130 13 10 2,766
3999 2 x 4 Hinged Specify Jun 2004 51 1 2 1,017
39565 Specify Jun 2007 123 55 2 2,106

a There were a total of 540 lead-related events reported to the ISPR, but only 468 events included in this summary table. The remaining lead-related events either occurred in lead models for which no device survival curves are presented due to an insufficient number of enrolled devices (n=5) or were subsequent or unlinked device events that did not affect the survival estimates.

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%
(87.5%, 92.7%)
87.2%
(84.2%, 90.2%)
81.8%
(78.1%, 85.5%)
76.6%
(72.3%, 81.0%)
3887 Pisces-Quad 96.8%
(92.3%, 100.0%)
88.9%
(81.5%, 96.3%)
85.8%
(77.4%, 94.2%)
84.0%
(75.2%, 92.9%)
3888 Pisces-Quad 91.7%
(87.8%, 95.6%)
90.3%
(86.0%, 94.6%)
85.5%
(79.3%, 91.7%)
84.2%
(77.6%, 90.8%)
3890 Pisces-Quad LZ 100.0%
NA
96.9%
(92.7%, 100.0%)
89.8%
(81.8%, 97.7%)
89.8%
(81.8%, 97.7%)
3891 Pisces-Quad LZ 80.1%
(71.5%, 88.7%)
77.2%
(68.0%, 86.5%)
- -
3776 Pisces-Octad 97.8%
(95.2%, 100.0%)
97.8%
(95.2%, 100.0%)
97.8%
(95.2%, 100.0%)
-
3777 Pisces-Octad 93.6%
(91.3%, 95.8%)
89.8%
(86.8%, 92.8%)
89.8%
(86.8%, 92.8%)
89.8%
(86.8%, 92.8%)
3778 Pisces-Octad 90.7%
(89.2%, 92.2%)
86.8%
(84.7%, 88.8%)
84.0%
(81.5%, 86.5%)
83.5%
(80.9%, 86.2%)
Surgical Leads
3986A Resume TL 87.3%
(79.3%, 95.2%)
87.3%
(79.3%, 95.2%)
84.5%
(75.0%, 93.9%)
-
3998 Specify 97.0%
(92.8%, 100.0%)
93.3%
(86.7%, 99.9%)
90.1%
(81.2%, 99.0%)
-
3999 2 x 4 Hinged Specify 96.7%
(90.3%, 100.0%)
93.6%
(84.7%, 100.0%)
- -
39565 Specify 97.9%
(94.9%, 100.0%)
97.9%
(94.9%, 100.0%)
97.9%
(94.9%, 100.0%)
-

 

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 72.8%
(67.9%, 77.7%)
68.7%
(63.1%, 74.2%)
66.0%
(59.9%, 72.1%)
66.0%
(59.9%, 72.1%)
3887 Pisces-Quad 81.8%
(72.1%, 91.5%)
79.6%
(69.1%, 90.0%)
- -
3888 Pisces-Quad 81.2%
(73.6%, 88.8%)
77.1%
(67.8%, 86.3%)
77.1%
(67.8%, 86.3%)
-
3890 Pisces-Quad LZ 86.5%
(76.6%, 96.5%)
- - -
3891 Pisces-Quad LZ - - - -
3776 Pisces-Octad - - - -
3777 Pisces-Octad 88.4%
(84.3%, 92.5%)
84.3%
(77.4%, 91.2%)
- -
3778 Pisces-Octad 81.2%
(77.5%, 84.9%)
77.4%
(71.1%, 83.8%)
- -
Surgical Leads
3986A Resume TL - - - -
3998 Specify - - - -
3999 2 x 4 Hinged Specify - - - -
39565 Specify - - - -

 

Device Survival Probability (95% Confidence Interval)Table 3 of 3
Model
Number
Family 9 yrs 10 yrs 11 yrs
Percutaneous Leads
3487A Pisces-Quad 66.0%
(59.9%, 72.1%)
62.3%
(54.5%, 70.0%)
59.8%
(51.0%, 68.7%)
3887 Pisces-Quad - - -
3888 Pisces-Quad - - -
3890 Pisces-Quad LZ - - -
3891 Pisces-Quad LZ - - -
3776 Pisces-Octad - - -
3777 Pisces-Octad - - -
3778 Pisces-Octad - - -
Surgical Leads
3986A Resume TL - - -
3998 Specify - - -
3999 2 x 4 Hinged Specify - - -
39565 Specify - - -

Extensions

From June 2004 to the report cut-off date of July 31, 2013, there were 2,757 extensions followed in the Implantable Systems Performance Registry (ISPR). Differences between the total number of extensions versus spinal cord stimulators (n=2,841) were due to the fact that some patients were subsequently re-implanted with an extension or implanted with 2 or more extensions.

An extension is a set of thin wires with a protective coating that connects the neurostimulator to the lead (not required for all neurostimulation systems). Over thirty-nine percent (39.5%) of the extensions were Model 37081 extensions, 24.7% were Model 7489 extensions, 19.8% were Model 37082 extensions, 7.6% were Model 7495 extensions, 6.8% were Model 37083 extensions, and less than 1.0% were Model 7471, Model 7472, Model 7496 and other models. The aggregate prospective follow-up time for all extensions was 57,897 months (4,825 years).

Extension EventsExtension Events

There were 16 product performance-related events with an underlying reported etiology related to the extension. Of these events, the majority were extension fractures (n=13). Of the 16 events, 15 were the first event attributable to an enrolled extension.

For the purposes of survival analysis, a device's follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event, 2) the occurrence of a non-product performance-related or censoring event, or 3) the device is event-free and censored at the patient's last follow-up prior to the data cut-off. A total of 15 extensions had follow-up time cut-off due to product performance-related events. There were 1,771 extensions censored in the survival analysis for the following reasons: patient expired, extension explanted, site termination, patient discontinued, patient lost to follow-up, other extension modification, therapy suspended, or non-product performance extension-related event without an associated intervention. The remaining 971 extensions, which were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Extension Survival Extension Survival

The figures and tables below represent extension survival and 95% confidence intervals where at least 20 extensions contributed to each 3-month interval. Currently, the 95% confidence intervals for all extension models overlap at all-time intervals, indicating that survival from extension-related events is not significantly different between the extension models across various applicable follow-up time points.

          
   

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

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Extension Characteristics
Model Number 7489
FDA Approval Date Oct 2002
Extensions Enrolled 681
Extensions Currently Active in Study 58
Device Events 3
Cumulative Months of Follow-up 15,709
Extension Event Total
Extension fracture 2
Medical device complicationa 1
Total Extension Events 3

a Reported as unknown problem with extension

Time Interval Survival Effective Sample Size
1 yr 99.6% 286
2 yrs 99.6% 292
3 yrs 98.8% 214
4 yrs 98.8% 140
5 yrs 98.8% 103
6 yrs 98.8% 76
7 yrs 98.8% 60
8 yrs 98.8% 50
at 105 mo 98.8% 21

 

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

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Extension Characteristics
Model Number 37081
FDA Approval Date Apr 2005
Extensions Enrolled 1,090
Extensions Currently Active in Study 410
Device Events 5
Cumulative Months of Follow-up 18,591
Extension Event Total
Extension fracture 5
Total Extension Events 5
Time Interval Survival Effective Sample Size
1 yr 99.9% 555
2 yrs 99.4% 333
3 yrs 98.6% 189
4 yrs 98.6% 102
5 yrs 98.6% 55
6 yrs 98.6% 21

 

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

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Extension Characteristics
Model Number 37082
FDA Approval Date Mar 2006
Extensions Enrolled 545
Extensions Currently Active in Study 209
Device Events 3
Cumulative Months of Follow-up 12,256
Extension Event Total
Extension fracture 2
Paraesthesiaa 1
Total Extension Events 3

a Physician reported shocking sensation at battery/extension connection

Time Interval Survival Effective Sample Size
1 yr 99.5% 346
2 yrs 99.2% 218
3 yrs 99.2% 127
4 yrs 99.2% 79
5 yrs 99.2% 54
6 yrs 99.2% 30
at 75 mo 99.2% 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

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Extension Characteristics
Model Number 37083
FDA Approval Date Sep 2005
Extensions Enrolled 187
Extensions Currently Active in Study 31
Device Events 4
Cumulative Months of Follow-up 4,365
Extension Event Total
Extension fracture 3
Device failurea 1
Total Extension Events 4

a Reported as extension failure

Time Interval Survival Effective Sample Size
1 yr 99.0% 105
2 yrs 97.0% 86
3 yrs 95.7% 54
4 yrs 95.7% 40
5 yrs 95.7% 23
at 63 mo 95.7% 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, survival from extension-related events is not statistically significantly different between the extension models across all applicable follow-up time points.

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 1,090 410 5 18,591
37082 37082 Mar 2006 545 209 3 12,256
37083 37083 Sep 2005 187 31 4 4,365
7489 7489 Oct 2002 681 58 3 15,709

a There were a total of 16 extension-related events reported to the ISPR, but only 15 events included in this summary table. The remaining 1 event was a subsequent event that did not affect the device 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%
(99.6%, 100.0%)
99.4%
(98.6%, 100.0%)
98.6%
(97.3%, 99.9%)
98.6%
(97.3%, 99.9%)
98.6%
(97.3%, 99.9%)
37082 99.5%
(98.8%, 100.0%)
99.2%
(98.2%, 100.0%)
99.2%
(98.2%, 100.0%)
99.2%
(98.2%, 100.0%)
99.2%
(98.2%, 100.0%)
37083 99.0%
(97.0%, 100.0%)
97.0%
(93.6%, 100.0%)
95.7%
(91.4%, 99.9%)
95.7%
(91.4%, 99.9%)
95.7%
(91.4%, 99.9%)
7489 99.6%
(98.9%, 100.0%)
99.6%
(98.9%, 100.0%)
98.8%
(97.5%, 100.0%)
98.8%
(97.5%, 100.0%)
98.8%
(97.5%, 100.0%)

 

Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Number 6 yrs 7 yrs 8 yrs
37081 98.6%
(97.3%, 99.9%)
- -
37082 99.2%
(98.2%, 100.0%)
- -
37083

- - -
7489 98.8%
(97.5%, 100.0%)
98.8%
(97.5%, 100.0%)
98.8%
(97.5%, 100.0%)

2013 Medtronic Product Performance Report: Data through July 31, 2013

United States