Spinal Cord Stimulation Systems
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 29, 2011. Forty-three centers enrolled and contributed patients to the spinal cord stimulation section of the report.
Patients
Of the 1,983 total spinal cord stimulation patients enrolled in the ISPR, 11.9% were implanted for the treatment of complex regional pain syndrome (CRPS), 42.9% were implanted for the treatment of failed back surgery syndrome, 43.9% were implanted for the treatment of other pain indications, and 1.3% were implanted for indications that were not specified in the database.
Primary SCS Treatment IndicationsPrimary SCS Treatment Indications
| Primary Treatment Indicationa | Total Enrolled Patients (Percent) |
|---|---|
| CRPS | 236 (11.9%) |
| CRPS I | 189 (9.5%) |
| CRPS II | 47 (2.4%) |
| Failed Back Surgery Syndrome | 851 (42.9%) |
| Postlaminectomy pain | 392 (19.8%) |
| Failed back syndrome (FBS) | 342 (17.2%) |
| Multiple back operations | 66 (3.3%) |
| Arachnoiditis | 23 (1.2%) |
| Combination back and leg pain | 22 (1.1%) |
| Unsuccessful disc surgery | 6 (0.3%) |
| Other | 870 (43.9%) |
| Radicular pain syndrome | 195 (9.8%) |
| Degenerative disc disease | 53 (2.7%) |
| Cervical pain | 4 (0.2%) |
| Diabetic neuropathy | 3 (0.2%) |
| Post herpetic neuralgia | 3 (0.2%) |
| Epidural fibrosis | 2 (0.1%) |
| Facial pain | 2 (0.1%) |
| Post herniorrhaphy pain | 1 (0.1%) |
| Other chronic pain | 585 (29.5%) |
| Other | 22 (1.1%) |
| Not Specified | 26 (1.3%) |
| Total Patients | 1,983 |
a Medtronic does not endorse use of our products that is contrary to the approved indications. Refer to product labeling for approved indications.
Event Summary
There were 973 events reported between June 2004 and July 29, 2011 in patients with spinal cord stimulation systems. Thirty percent of these events (295/973) were categorized as product performance-related and are presented graphically within this report. In addition, there were 656 non-product performance events and 53 deaths reported 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=1,983) |
|---|---|---|---|
| Lead migration/dislodgment | 157 | 97 | 4.89% |
| Undesirable change in stimulationc | 48 | 27 | 1.36% |
| Lead fracture | 40 | 26 | 1.31% |
| High impedance | 15 | 9 | 0.45% |
| Extension fracture | 11 | 6 | 0.3% |
| Medical device complicationd | 6 | 4 | 0.2% |
| Recharging unable to rechargee | 4 | 4 | 0.2% |
| Device failuref | 3 | 2 | 0.1% |
| Therapeutic productive ineffectiveg | 2 | 1 | 0.05% |
| Back disorderh | 1 | 1 | 0.05% |
| Broken bond wire | 1 | 1 | 0.05% |
| Change in sensation of stimulationi | 1 | 1 | 0.05% |
| Device malfunctionj | 1 | 1 | 0.05% |
| Failure of implantk | 1 | 1 | 0.05% |
| Impedance NOS | 1 | 1 | 0.05% |
| Low impedance | 1 | 1 | 0.05% |
| Paraesthesial | 1 | 1 | 0.05% |
| Not Coded | 2 | 2 | 0.1% |
| Total | 295 | 163 | 8.22% |
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=3) or lead (n=45)
d Includes 2 events reported as damaged leads, 2 lead malfunctions, 1 lead damaged contacts, and 1 unknown problem with an extension
e Patient was unable to recharge due to device related issue
f Includes 2 events reported as damaged electrodes and 1 extension failure
g Includes 2 events reported as loss of paraesthesia to bilateral lower extremities due to a lead related issue
h Physician reported they were unable to program SCS leads due to pressure in back when device was on
i Physicians reported effective stimulation coverage could not be obtained due to device issue
j Physician reported failure of lead electrodes
k Physicians reported extension and lead fracture
l Physician reported shocking sensation at battery/extension connection
A total of 269 (91.2%) of the 295 product performance events were related to the lead, 15 (5.1%) were related to the extension, 4 (1.4%) were related to the stimulator, 3 (1.0%) were related to programming/stimulation, 2 (0.7%) were related to an external device, 1 (0.3%) was related to incisional site/device tract, and 1 (0.3%) was related to recharging process.
| Neurostimulation System Non-Product Performance Events (including adverse events and device events, deaths excluded) | |
| Eventsa | Number of Non-Product Performance Events |
|---|---|
| Neurostimulator expected battery depletion | 234 |
| Therapeutic product ineffective | 83 |
| Implant site pain | 83 |
| Implant site infection | 46 |
| Pain | 26 |
| Undesirable change in stimulationb | 26 |
| Change in sensation of stimulation | 24 |
| Neurostimulator migration | 19 |
| Recharging unable to rechargec | 15 |
| Implant site erosion | 11 |
| Implant site erythema | 8 |
| Implant site effusion | 5 |
| Infection | 5 |
| Medical device complicationd | 5 |
| Wound dehiscence | 5 |
| Othere | 61 |
| Total | 656 |
a MedDRA Preferred Term
b Undesirable change in stimulation reported by the physician with an etiology that was not device related
c Patient was unable to recharge due to an issue not related to the device
d Includes 2 events reported as damaged leads, 2 lead malfunctions, 1 lead damaged contacts, and 1 unknown problem with an extension
e Composed of 41 event codes that include less than 5 patients each and events that had not been MedDRA coded at the time of the report cut-off (n=5)
There were 53 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, 52.8% of patient deaths occurred in patients receiving therapy for pain indications in the unspecified "other" category, 41.5% for failed back, and 5.7% for CRPS.
| Death by Primary Indication | |
| Primary Indication | N (%) |
|---|---|
| CRPS | 3 (5.7%) |
| Failed Back | 22 (41.5%) |
| Other | 28 (52.8%) |
| Total | 53 (100%) |
Spinal Cord Stimulators
From June 2004 to the report cut-off date of July 29, 2011, 2,259 spinal cord stimulators were followed in the Implantable Systems Performance Registry (ISPR). The difference between the total number of patients (n=1,983) 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%) of the spinal cord stimulators were Synergy, 20.4% were RestoreUltra, 19.9% were Restore, 18.0% were PrimeAdvanced, 11.2% were RestoreAdvanced, 4.6% were Itrel 3, and a smaller number were RestorePrime (2.3%), Synergy Versitrel (1.7%), or SynergyPlus+ (1.1%). The aggregate total prospective follow-up time for all spinal cord stimulators was 53,606 months (4,467 years).
There were 4 product performance-related events with an underlying reported etiology related to spinal cord stimulator function. For spinal cord stimulators in the ISPR, the current return rate to Medtronic Returned Product Analysis (RPA) was 117/543 (21.5%). 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 4 spinal cord stimulator events was confirmed by Medtronic RPA as a broken bond wire. The remaining 3 spinal cord stimulators with performance-related events were not returned to Medtronic RPA but were assigned as device related by the physician as undesirable change in stimulation.
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. In addition to the 4 stimulators which were cut-off due to product performance-related events, there were 1,479 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 776 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 Survival
The figures and tables below represent spinal cord stimulator survival and 95% confidence intervals where at least 20 spinal cord stimulators contributed to each 3-month interval. Currently, 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.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | Itrel 3 |
| FDA Approval Date | Aug 1995 |
| Neurostimulators Enrolled | 103 |
| Neurostimulators Currently Active in Study | 13 |
| Device Events | 0 |
| Cumulative Months of Follow-up | 3,506 |
| Stimulator Event | Total |
|---|---|
| Total Stimulator Events | 0 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 67 |
| 2 yrs | 100.0% | 49 |
| 3 yrs | 100.0% | 38 |
| 4 yrs | 100.0% | 23 |
Model 7425 Itrel 3: Specifications
| Height | 2.2 in (55 mm) |  |
| 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.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | Synergy |
| FDA Approval Date | Nov 1999 |
| Neurostimulators Enrolled | 470 |
| Neurostimulators Currently Active in Study | 60 |
| Device Events | 3 |
| Cumulative Months of Follow-up | 16,273 |
| Stimulator Event | Total |
|---|---|
| Undesirable change in stimulation | 2 |
| Broken bond wire | 1 |
| Total Stimulator Events | 3 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 286 |
| 2 yrs | 99.7% | 251 |
| 3 yrs | 99.7% | 174 |
| 4 yrs | 99.0% | 102 |
| 5 yrs | 97.8% | 50 |
| 6 yrs | 97.8% | 25 |
| at 75 mo | 97.8% | 22 |
Model 7427 Synergy: Specifications
| Height | 2.4 in (61 mm) |  |
| 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
Data are shown if there are at least 20 devices in each 3-month interval.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | Synergy Versitrel |
| FDA Approval Date | Dec 2001 |
| Neurostimulators Enrolled | 39 |
| Neurostimulators Currently Active in Study | 1 |
| Device Events | 0 |
| Cumulative Months of Follow-up | 1,252 |
| Stimulator Event | Total |
|---|---|
| Total Stimulator Events | 0 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 23 |
| at 18 mo | 100.0% | 20 |
Model 7427V Synergy Versitrel: Specifications
| Height | 2.4 in (61 mm) |  |
| 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.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | RestorePrime |
| FDA Approval Date | Mar 2006 |
| Neurostimulators Enrolled | 53 |
| Neurostimulators Currently Active in Study | 11 |
| Device Events | 0 |
| Cumulative Months of Follow-up | 1,301 |
| Stimulator Event | Total |
|---|---|
| Total Stimulator Events | 0 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 40 |
| 2 yrs | 100.0% | 22 |
| at 27 mo | 100.0% | 20 |
Model 37701 RestorePrime: Specifications
| Height | 2.6 in (65 mm) |  |
| 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.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | PrimeAdvanced |
| FDA Approval Date | Jul 2006 |
| Neurostimulators Enrolled | 406 |
| Neurostimulators Currently Active in Study | 177 |
| Device Events | 1 |
| Cumulative Months of Follow-up | 5,866 |
| Stimulator Event | Total |
|---|---|
| Undesirable change in stimulation | 1 |
| Total Stimulator Events | 1 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 99.6% | 215 |
| 2 yrs | 99.6% | 88 |
| 3 yrs | 99.6% | 27 |
| at 39 mo | 99.6% | 20 |
Model 37702 PrimeAdvanced: Specifications
| Height | 2.6 in (65 mm) |  |
| 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.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | Restore |
| FDA Approval Date | Apr 2005 |
| Neurostimulators Enrolled | 450 |
| Neurostimulators Currently Active in Study | 124 |
| Device Events | 0 |
| Cumulative Months of Follow-up | 13,236 |
| Stimulator Event | Total |
|---|---|
| Total Stimulator Events | 0 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 347 |
| 2 yrs | 100.0% | 252 |
| 3 yrs | 100.0% | 158 |
| 4 yrs | 100.0% | 81 |
| 5 yrs | 100.0% | 28 |
Model 37711 Restore: Specifications
| Height | 2.6 in (65 mm) |  |
| 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 Stimulation Events
Data are shown if there are at least 20 devices in each 3-month interval.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | RestoreAdvanced |
| FDA Approval Date | Jul 2006 |
| Neurostimulators Enrolled | 253 |
| Neurostimulators Currently Active in Study | 123 |
| Device Events | 0 |
| Cumulative Months of Follow-up | 5,437 |
| Stimulator Event | Total |
|---|---|
| Total Stimulator Events | 0 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 165 |
| 2 yrs | 100.0% | 103 |
| 3 yrs | 100.0% | 57 |
| at 45 mo | 100.0% | 28 |
Model 37713 RestoreAdvanced: Specifications
| Height | 2.6 in (65 mm) |  |
| 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 Stimulation Events
Data are shown if there are at least 20 devices in each 3-month interval.
| Spinal Cord Stimulator Characteristics | |
|---|---|
| Model Name | RestoreUltra |
| FDA Approval Date | Jan 2008 |
| Neurostimulators Enrolled | 461 |
| Neurostimulators Currently Active in Study | 295 |
| Device Events | 0 |
| Cumulative Months of Follow-up | 5,870 |
| Stimulator Event | Total |
|---|---|
| Total Stimulator Events | 0 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 250 |
| 2 yrs | 100.0% | 71 |
| at 33 mo | 100.0% | 22 |
Model 37712 RestoreUltra: Specifications
| Height | 2.1 in (54 mm) |  |
| 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 |
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 Events |
Cumulative Months of Follow-up |
| Itrel3 | Itrel3 | Aug 1995 |
103 | 13 | 0 | 3,506 |
| Synergy | Synergy | Nov 1999 |
470 | 60 | 3 | 16,273 |
| Synergy Versitrel |
Synergy | Dec 2001 |
39 | 1 | 0 | 1,252 |
| Restore | Restore | Apr 2005 |
450 | 124 | 0 | 13,236 |
| Restore Prime |
Restore Prime |
Mar 2006 |
53 | 11 | 0 | 1,301 |
| Restore Advanced |
Restore | Jul 2006 |
253 | 123 | 0 | 5,437 |
| Prime Advanced |
Prime Advanced |
Jul 2006 |
406 | 177 | 1 | 5,866 |
| RestoreUltra | Restore | Jan 2008 |
461 | 295 | 0 | 5,870 |
| Device Survival Probability (95% Confidence Interval) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Model Name | 1 yr | 2 yrs | 3 yrs | 4 yrs | 5 yrs | 6 yrs | |||
| Itrel3 | 100.0% NA |
100.0% NA |
100.0% NA |
100.0% NA |
- | - | |||
| Synergy | 100.0% NA |
99.7% (99.0%, 100.0%) |
99.7% (99.0%, 100.0%) |
99.0% (97.6%, 100.0%) |
97.8% (95.1%, 100.0%) |
97.8% (95.1%, 100.0%) |
|||
| Synergy Versitrel | 100.0% NA |
- | - | - | - | - | |||
| Restore | 100.0% NA |
100.0% NA |
100.0% NA |
100.0% NA |
100.0% NA |
- | |||
| RestorePrime | 100.0% NA |
100.0% NA |
- | - | - | - | |||
| RestoreAdvanced | 100.0% NA |
100.0% NA |
100.0% NA |
- | - | - | |||
| PrimeAdvanced | 99.6% (98.8%, 100.0%) |
99.6% (98.8%, 100.0%) |
99.6% (98.8%, 100.0%) |
- | - | - | |||
| RestoreUltra | 100.0% NA |
100.0% NA |
- | - | - | - | |||
Leads
From June 2004 to the report cut-off date of July 29, 2011, there were 3,816 leads followed in the Implantable Systems Performance Registry (ISPR). Differences between the total number of leads versus spinal cord stimulators (n=1,983) 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). Eighty-eight percent (88%) of leads in ISPR were percutaneous leads (3,367/3,816) including 51% (1,960/3,816) in the Pisces-Octad lead family, 30% (1,147/3,816) in the Pisces-Quad lead family, and 7% (260/3,816) in the Pisces-Quad LZ lead family. Ten percent (10%) of leads (396/3,816) were surgical leads. A small number of leads (53/3,816) were designated as Other (1%). The aggregate total prospective follow-up time for all leads was 106,121 months (8,843 years).
There were 269 product performance-related events with an underlying reported etiology related to the lead. Of these events, the majority were lead migration/dislodgements (n=156), undesirable change in stimulation (n=45), or lead fracture (n=40). Of the 269 events, 239 were the first event attributable to an enrolled lead. There were 228 events in 3,367 (6.7%) percutaneous leads and 11 events in 396 (2.7%) surgical leads.
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. In addition to the 239 leads which were cut-off due to product performance-related events there were 2,105 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 1,472 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.
The figures and tables below represent lead survival and 95% confidence intervals where at least 20 leads contributed to each 3-month interval. Currently, at 2 years of follow-up, the 95% confidence interval for Specify Model 39565 (surgical lead) does not overlap with percutaneous lead Pisces-Quad Model 3487A, Pisces-Octad Model 3777, Pisces-Octad Model 3778, and Pisces-Quad LZ Model 3891 suggesting that Model 39565 has statistically significantly better performance than Models 3487A, 3777, 3778, and 3891 at this time point.
At 3 years, the 95% confidence interval for Pisces-Quad LZ Model 3891 leads does not overlap with any other applicable lead models, indicating that Model 3891 may not perform as well as other lead models at 3 years. 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3487A |
| FDA Approval Date | May 1988 |
| Leads Enrolled | 712 |
| Leads Currently Active in Study | 321 |
| Device Events | 58 |
| Cumulative Months of Follow-up | 26,958 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgment | 21 |
| Undesirable change in stimulation | 17 |
| Lead fracture | 11 |
| High impedance | 8 |
| Low impedance | 1 |
| Total Lead Events | 58 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 94.0% | 397 |
| 2 yrs | 90.8% | 278 |
| 3 yrs | 89.2% | 209 |
| 4 yrs | 87.3% | 171 |
| 5 yrs | 85.9% | 109 |
| 6 yrs | 84.0% | 74 |
| 7 yrs | 75.7% | 51 |
| 8 yrs | 75.7% | 37 |
| 9 yrs | 75.7% | 25 |
| at 114 mo | 75.7% | 20 |
Model 3487A Pisces-Quad: Specifications
| Device Name | Pisces Standard |  |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3887 |
| FDA Approval Date | Jan 1997 |
| Leads Enrolled | 151 |
| Leads Currently Active in Study | 34 |
| Device Events | 12 |
| Cumulative Months of Follow-up | 7,645 |
| Lead Event | Total |
|---|---|
| Lead fracture | 5 |
| Lead migration/dislodgment | 3 |
| Undesirable change in stimulaiton | 2 |
| Medical device complicationa | 1 |
| Not Coded | 1 |
| Total Lead Events | 12 |
a Reported as lead damaged contacts
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 96.8% | 76 |
| 2 yrs | 89.4% | 71 |
| 3 yrs | 87.1% | 77 |
| 4 yrs | 85.7% | 57 |
| 5 yrs | 85.7% | 42 |
| 6 yrs | 83.4% | 38 |
| at 81 mo | 83.4% | 21 |
Model 3887 Pisces-Quad: Specifications
| Device Name | Pisces Compact |  |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3888 |
| FDA Approval Date | Nov 1992 |
| Leads Enrolled | 284 |
| Leads Currently Active in Study | 73 |
| Device Events | 16 |
| Cumulative Months of Follow-up | 10,489 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgment | 13 |
| Undesirable change in stimulation | 2 |
| Lead fracture | 1 |
| Total Lead Events | 16 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 96.7% | 161 |
| 2 yrs | 95.4% | 99 |
| 3 yrs | 91.4% | 68 |
| 4 yrs | 90.0% | 62 |
| 5 yrs | 86.7% | 48 |
| 6 yrs | 81.6% | 31 |
| at 90 mo | 81.6% | 20 |
Model 3888 Pisces-Quad: Specifications
| Device Name | Pisces Plus |  |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3890 |
| FDA Approval Date | Sep 2002 |
| Leads Enrolled | 133 |
| Leads Currently Active in Study | 32 |
| Device Events | 6 |
| Cumulative Months of Follow-up | 4,598 |
| Lead Event | Total |
|---|---|
| Lead fracture | 2 |
| Lead migration/dislodgment | 2 |
| Undesirable change in stimulation | 2 |
| Total Lead Events | 6 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 57 |
| 2 yrs | 97.2% | 71 |
| 3 yrs | 94.5% | 68 |
| 4 yrs | 89.7% | 29 |
| at 51 mo | 89.7% | 21 |
Model 3890 Pisces-Quad LZ: Specifications
| Device name | Pisces Z Quad |  |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3891 |
| FDA Approval Date | Sep 2002 |
| Leads Enrolled | 112 |
| Leads Currently Active in Study | 18 |
| Device Events | 26 |
| Cumulative Months of Follow-up | 3,026 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgment | 14 |
| Lead fracture | 6 |
| Undesirable change in stimulation | 4 |
| Device failurea | 2 |
| Total Lead Events | 26 |
a Reported as damaged electrodes
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 83.3% | 73 |
| 2 yrs | 80.6% | 45 |
| 3 yrs | 65.7% | 25 |
| at 42 mo | 65.7% | 21 |
Model 3891 Pisces-Quad LZ: Specifications
| Device Name | Pisces Z Quad Compact |
 |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3776 |
| FDA Approval Date | Nov 2005 |
| Leads Enrolled | 109 |
| Leads Currently Active in Study | 30 |
| Device Events | 3 |
| Cumulative Months of Follow-up | 2,079 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgement | 2 |
| Undesirable change in stimulation | 1 |
| Total Lead Events | 3 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 96.9% | 67 |
| 2 yrs | 96.9% | 31 |
| 3 yrs | 96.9% | 21 |
| at 39 mo | 96.9% | 20 |
Model 3776 Pisces-Octad: Specifications
| Device Name | 1x8 Sub-compact |
 |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3777 |
| FDA Approval Date | Mar 2005 |
| Leads Enrolled | 586 |
| Leads Currently Active in Study | 178 |
| Device Events | 35 |
| Cumulative Months of Follow-up | 13,536 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgment | 24 |
| Undesirable change in stimulation | 7 |
| Medical device complicationa | 2 |
| High impedance | 1 |
| Lead fracture | 1 |
| Total Lead Events | 35 |
a Reported as damaged leads
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 94.7% | 377 |
| 2 yrs | 91.6% | 235 |
| 3 yrs | 91.6% | 132 |
| 4 yrs | 91.6% | 74 |
| 5 yrs | 89.9% | 32 |
Model 3777 Pisces-Octad: Specifications
| Device Name | 1x8 Standard |
 |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3778 |
| FDA Approval Date | Mar 2005 |
| Leads Enrolled | 1,265 |
| Leads Currently Active in Study | 726 |
| Device Events | 71 |
| Cumulative Months of Follow-up | 21,974 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgment | 57 |
| Lead fracture | 5 |
| Undesirable change in stimulation | 4 |
| Medical device complicationa | 2 |
| Back disorderb | 1 |
| High impedance | 1 |
| Impedance NOS | 1 |
| Total Lead Events | 71 |
a Reported as lead malfunctions
b Physician reported they were unable to program SCS leads due to pressure in back when device was on
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 95.0% | 726 |
| 2 yrs | 92.1% | 374 |
| 3 yrs | 91.1% | 188 |
| 4 yrs | 89.5% | 55 |
| at 54 mos | 89.5% | 22 |
Model 3778 Pisces-Octad: Specifications
| Device Name | 1x8 Compact |
 |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3986A |
| FDA Approval Date | Jul 1997 |
| Leads Enrolled | 74 |
| Leads Currently Active in Study | 31 |
| Device Events | 2 |
| Cumulative Months of Follow-up | 1,758 |
| Lead Event | Total |
|---|---|
| Undesirable change in stimulation | 2 |
| Total Lead Events | 2 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 96.2% | 39 |
| 2 yrs | 96.2% | 28 |
| 3 yrs | 96.2% | 23 |
| at 39 mo | 96.2% | 20 |
Model 3986A Resume TL: Specifications
| Device Name | Resume TL |  |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3998 |
| FDA Approval Date | Feb 1998 |
| Leads Enrolled | 126 |
| Leads Currently Active in Study | 22 |
| Device Events | 6 |
| Cumulative Months of Follow-up | 4,366 |
| Lead Event | Total |
|---|---|
| Lead fracture | 3 |
| Device malfunctiona | 1 |
| Lead migration/dislodgment | 1 |
| Undesirable change in stimulation | 1 |
| Total Lead Events | 6 |
a Reported as failure of lead electrodes
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 97.5% | 76 |
| 2 yrs | 94.2% | 53 |
| 3 yrs | 92.0% | 32 |
| at 42 mo | 92.0% | 23 |
Model 3998 Specify: Specifications
| Device Name | Specify |  |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 39565 |
| FDA Approval Date | Jun 2007 |
| Leads Enrolled | 89 |
| Leads Currently Active in Study | 57 |
| Device Events | 1 |
| Cumulative Months of Follow-up | 1,466 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgment | 1 |
| Total Lead Events | 1 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 98.6% | 57 |
| 2 yrs | 98.6% | 24 |
Model 39565 Specify: Specifications
| Device Name | Specify 5-6-5 |  |
|---|---|---|
| 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.
| Lead Characteristics | |
|---|---|
| Model Number | 3999 |
| FDA Approval Date | Jun 2004 |
| Leads Enrolled | 50 |
| Leads Currently Active in Study | 5 |
| Device Events | 2 |
| Cumulative Months of Follow-up | 1,384 |
| Lead Event | Total |
|---|---|
| Lead migration/dislodgment | 2 |
| Total Lead Events | 2 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 96.7% | 39 |
| 2 yrs | 94.1% | 34 |
| at 30 mo | 94.1% | 23 |
Model 3999 2x4 Hinged: Specifications
| Device Name | 2x4 Hinged Specify |  |
|---|---|---|
| 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 | |
At 2 years of follow-up, surgical lead Model 39565 has statistically significantly better performance than percutaneous lead Models 3487A, 3777, 3778, and 3891. At 3 years of follow-up, the data indicate that Model 3891 does not perform as well as other lead models. As of February 6, 2008, Medtronic discontinued worldwide distribution of the Pisces-Quad LZ lead (which includes the 3890 and 3891 leads) due to performance relative to other percutaneous leads and minimal commercial demand for the product.
| Lead Characteristics | ||||||
|---|---|---|---|---|---|---|
| Model Number | Family | FDA Approval Date | Leads Enrolled | Leads Currently Active in Study | Device Eventsa | Cumulative Months of Follow-up |
| Percutaneous Leads | ||||||
| 3487A | Pisces-Quad | May 1988 | 712 | 321 | 58 | 26,958 |
| 3776 | Pisces-Octad | Nov 2005 | 109 | 30 | 3 | 2,079 |
| 3777 | Pisces-Octad | Mar 2005 | 586 | 178 | 35 | 13,536 |
| 3778 | Pisces-Octad | Mar 2005 | 1,265 | 726 | 71 | 21,974 |
| 3887 | Pisces-Quad | Jan 1997 | 151 | 34 | 12 | 7,645 |
| 3888 | Pisces-Quad | Nov 1992 | 284 | 73 | 16 | 10,489 |
| 3890 | Pisces-Quad LZ | Sep 2002 | 133 | 32 | 6 | 4,598 |
| 3891 | Pisces-Quad LZ | Sep 2002 | 112 | 18 | 26 | 3,026 |
| Surgical Leads | ||||||
| 3986A | Resume TL | Jul 1997 | 74 | 31 | 2 | 1,758 |
| 3998 | Specify | Feb 1998 | 126 | 22 | 6 | 4,366 |
| 3999 | 2 x 4 Hinged Specify | Jun 2004 | 50 | 5 | 2 | 1,384 |
| 39565 | Specify | Jun 2007 | 89 | 57 | 1 | 1,466 |
a There were a total of 269 lead-related events reported to the ISPR, but only 238 events included in this summary table. The remaining events either occurred in lead models for which no device survival curves are presented due to an insufficient number of enrolled devices (ie, Model 3892), were subsequent events that did not affect the device survival estimates, or were events that were not able to be associated with a specific lead (eg, the event had a lead etiology, but no lead serial number or lot number was specified).
| Device Survival Probability (95% Confidence Interval) – Table 1 of 2 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Model Name |
Family | 1 yr | 2 yrs | 3 yrs | 4 yrs | 5 yrs | |||
| Percutaneous Leads | |||||||||
| 3487A | Pisces-Quad | 94.0% (91.7%, 96.2%) |
90.8% (87.9%, 93.7%) |
89.2% (86.0%, 92.4%) |
87.3% (83.7%, 91.0%) |
85.9% (81.8%, 90.1%) |
|||
| 3776 | Pisces-Octad | 96.9% (93.4%, 100.0%) |
96.9% (93.4%, 100.0%) |
96.9% (93.4%, 100.0%) |
- | - | |||
| 3777 | Pisces-Octad | 94.7% (92.6%, 96.8%) |
91.6% (88.8%, 94.4%) |
91.6% (88.8%, 94.4%) |
91.6% (88.8%, 94.4%) |
89.9% (85.7%, 94.2%) |
|||
| 3778 | Pisces-Octad | 95.0% (93.6%, 96.4%) |
92.1% (90.1%, 94.1%) |
91.1% (88.8%, 93.4%) |
89.5% (85.5%, 93.5%) |
- | |||
| 3887 | Pisces-Quad | 96.8% (92.4%, 100.0%) |
89.4% (82.3%, 96.5%) |
87.1% (79.4%, 94.7%) |
85.7% (77.7%, 93.7%) |
85.7% (77.7%, 93.7%) |
|||
| 3888 | Pisces-Quad | 96.7% (94.1%, 99.4%) |
95.4% (92.2%, 98.6%) |
91.4% (85.8%, 96.9%) |
90.0% (83.9%, 96.1%) |
86.7% (79.2%, 94.1%) |
|||
| 3890 | Pisces-Quad LZ | 100.0% NA |
97.2% (93.2%, 100.0%) |
94.5% (89.2%, 99.8%) |
89.7% (81.4%, 98.0%) |
- | |||
| 3891 | Pisces-Quad LZ | 83.3% (75.5%, 91.2%) |
80.6% (72.1%, 89.1%) |
65.7% (53.3%, 78.1%) |
- | - | |||
| Surgical Leads | |||||||||
| 3986A | Resume TL | 96.2% (91.0%, 100.0%) |
96.2% (91.0%, 100.0%) |
96.2% (91.0%, 100.0%) |
- | - | |||
| 3998 | Specify | 97.5% (93.9%, 100.0%) |
94.2% (88.6%, 99.9%) |
92.0% (84.9%, 99.1%) |
- | - | |||
| 3999 | 2 x 4 Hinged Specify | 96.7% (90.3%, 100.0%) |
94.1% (86.1%, 100.0%) |
- | - | - | |||
| 39565 | Specify | 98.6% (95.9%, 100.0%) |
98.6% (95.9%, 100.0%) |
- | - | - | |||
| Device Survival Probability (95% Confidence Interval) – Table 2 of 2 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Model Name |
Family | 6 yrs | 7 yrs | 8 yrs | 9 yrs | ||||
| Percutaneous Leads | |||||||||
| 3487A | Pisces-Quad | 84.0% (79.1%, 88.8%) |
75.7% (67.9%, 83.6%) |
75.7% (67.9%, 83.6%) |
75.7% (67.9%, 83.6%) |
||||
| 3776 | Pisces-Octad | - | - | - | - | ||||
| 3777 | Pisces-Octad | - | - | - | - | ||||
| 3778 | Pisces-Octad | - | - | - | - | ||||
| 3887 | Pisces-Quad | 83.4% (74.4%, 92.4%) |
- | - | - | ||||
| 3888 | Pisces-Quad | 81.6% (71.8%, 91.5%) |
- | - | - | ||||
| 3890 | Pisces-Quad LZ | - | - | - | - | ||||
| 3891 | Pisces-Quad LZ | - | - | - | - | ||||
| 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 29, 2011, there were 2,316 extensions followed in the Implantable Systems Performance Registry (ISPR). Differences between the total number of extensions versus spinal cord stimulators (n=1,983) 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). Thirty-three percent (33%) of the extensions were Model 37081 extensions, 30.1% were Model 7489 extensions, 19.0% were Model 37082 extensions, 8.6% were Model 7495 extensions, 7.8% were Model 37083 extensions, and <1% were Model 7472, Model 7496 and other models. The aggregate total prospective follow-up time for all extensions was 75,616 months (6,301 years).
There were 15 product performance-related events with an underlying reported etiology related to the extension. Of these events, the majority were extension fractures (n=11). Of the 15 events, 14 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. In addition to the 14 extensions which were cut-off due to product performance-related events there, were 1,584 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 718 extensions that were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.
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 Extension Family: Survival from Extension Events
Data are shown if there are at least 20 devices in each 3-month interval.
| Extension Characteristics | |
|---|---|
| Model Number | 7489 |
| FDA Approval Date | Oct 2002 |
| Extensions Enrolled | 696 |
| Extensions Currently Active in Study | 110 |
| Device Events | 3 |
| Cumulative Months of Follow-up | 26,496 |
| 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 | 99.8% | 446 |
| 2 yrs | 99.8% | 427 |
| 3 yrs | 99.2% | 313 |
| 4 yrs | 99.2% | 188 |
| 5 yrs | 99.2% | 112 |
| 6 yrs | 99.2% | 60 |
| 7 yrs | 99.2% | 21 |
Model 7489 Extension Family: Specifications
| Device Name | 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 Extension Family: Survival from Extension Events
Data are shown if there are at least 20 devices in each 3-month interval.
| Extension Characteristics | |
|---|---|
| Model Number | 37081 |
| FDA Approval Date | Apr 2005 |
| Extensions Enrolled | 764 |
| Extensions Currently Active in Study | 302 |
| Device Events | 4 |
| Cumulative Months of Follow-up | 15,345 |
| Extension Event | Total |
|---|---|
| Extension fracture | 4 |
| Total Extension Events | 4 |
| Time Interval | Survival | Effective Sample Size |
|---|---|---|
| 1 yr | 100.0% | 508 |
| 2 yrs | 99.4% | 276 |
| 3 yrs | 98.4% | 128 |
| 4 yrs | 98.4% | 31 |
| at 51 mo | 98.4% | 22 |
Model 37081 Extension Family: Specifications
| Device Name | 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 Extension Family: Survival from Extension Events
Data are shown if there are at least 20 devices in each 3-month interval.
| Extension Characteristics | |
|---|---|
| Model Number | 37082 |
| FDA Approval Date | Mar 2006 |
| Extensions Enrolled | 439 |
| Extensions Currently Active in Study | 182 |
| Device Events | 3 |
| Cumulative Months of Follow-up | 9,159 |
| 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 | 99.4% | 311 |
| 2 yrs | 99.1% | 179 |
| 3 yrs | 99.1% | 75 |
| 4 yrs | 99.1% | 32 |
| at 54 mo | 99.1% | 20 |
37082 Extension Family: Specifications
| Device Name | 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 Extension Family: Survival from Extension Events
Data are shown if there are at least 20 devices in each 3-month interval.
| Extension Characteristics | |
|---|---|
| Model Number | 37083 |
| FDA Approval Date | Sep 2005 |
| Extensions Enrolled | 180 |
| Extensions Currently Active in Study | 64 |
| Device Events | 4 |
| Cumulative Months of Follow-up | 4,757 |
| 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 | 99.3% | 134 |
| 2 yrs | 97.5% | 84 |
| 3 yrs | 96.2% | 56 |
| 4 yrs | 96.2% | 26 |
| at 51 mo | 96.2% | 20 |
Model 37083 Extension Family: Specifications
| Device Name | 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 |
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 |
| 7489 | 7489 | Oct 2002 | 696 | 110 | 3 | 26,496 |
| 37081 | 37081 | Apr 2005 | 764 | 302 | 4 | 15,345 |
| 37082 | 37082 | Mar 2006 | 439 | 182 | 3 | 9,159 |
| 37083 | 37083 | Sep 2005 | 180 | 64 | 4 | 4,757 |
a There were a total of 15 extension-related events reported to the ISPR, but only 14 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 | |||||
| 7489 | 99.8% (99.3%, 100.0%) |
99.8% (99.3%, 100.0%) |
99.2% (98.3%, 100.0%) |
99.2% (98.3%, 100.0%) |
99.2% (98.3%, 100.0%) |
|||||
| 37081 | 100.0% NA |
99.4% (98.6%, 100.0%) |
98.4% (96.8%, 100.0%) |
98.4% (96.8%, 100.0%) |
- | |||||
| 37082 | 99.4% (98.6%, 100.0%) |
99.1% (98.0%, 100.0%) |
99.1% (98.0%, 100.0%) |
99.1% (98.0%, 100.0%) |
- | |||||
| 37083 | 99.3% (97.8%, 100.0%) |
97.5% (94.7%, 100.0%) |
96.2% (92.3%, 100.0%) |
96.2% (92.3%, 100.0%) |
- | |||||
| Device Survival Probability (95% Confidence Interval) – Table 2 of 2 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Model Number | 6 yrs | 7 yrs | 8 yrs | 9 yrs | 10 yrs | |||||
| 7489 | 99.2% (98.3%, 100.0%) |
99.2% (98.3%, 100.0%) |
- | - | - | |||||
| 37081 | - |
- | - | - | - | |||||
| 37082 | - |
- | - | - | - | |||||
| 37083 | - |
- | - | - | - | |||||
2011 Medtronic Product Performance Report: Data through July 29, 2011