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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, 2012. Forty-four centers enrolled and contributed patients to the spinal cord stimulation section of the report.


Patients

Of the 2,210 total spinal cord stimulation patients enrolled in the ISPR, 44.8% were implanted for the treatment of other pain indications, 43.3% were implanted for the treatment of failed back surgery syndrome, 11.6% 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 Treatment Indicationa Total Enrolled Patients (Percent)
Other 990 (44.8%)
Radicular pain syndrome 231 (10.5%)
Degenerative disc disease 70 (3.2%)
Cervical pain 8 (0.4%)
Diabetic neuropathy 6 (0.3%)
Post herpetic neuralgia 4 (0.2%)
Epidural fibrosis 2 (0.1%)
Facial pain 2 (0.1%)
Post herniorrhaphy pain 1 (0%)
Other chronic pain 593 (26.8%)
Other 69 (3.1%)
Failed Back Surgery Syndrome 956 (43.3%)
Postlaminectomy pain 450 (20.4%)
Failed back syndrome (FBS) 343 (15.5%)
Combination back and leg pain 72 (3.3%)
Multiple back operations 64 (2.9%)
Arachnoiditis 21 (1%)
Unsuccessful disc surgery 6 (0.3%)
CRPS 256 (11.6%)
CRPS I 196 (8.9%)
CRPS II 60 (2.7%)
Not Specified 8 (0.4%)
Total Patients 2,210

a Refer to product labeling for approved indications.

 

Event Summary

There were 1,317 events reported between June 2004 and July 31, 2012 in patients with spinal cord stimulation systems. Thirty-four percent of these events (447/1,317) were categorized as product performance-related and are presented graphically within this report. The 447 product performance events occurred in 219 of the 2,210 total patients (9.9%) enrolled. In addition, there were 805 non-product performance events and 65 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=2,210)
Lead migration/dislodgment 241 134 6.06%
High impedance 48 21 0.95%
Undesirable change in stimulationc 46 26 1.18%
Lead fracture 43 29 1.31%
Medical device complicationd 23 12 0.54%
Extension fracture 13 8 0.36%
Recharging unable to rechargee 9 9 0.41%
Device malfunctionf 6 5 0.23%
Low impedance 5 2 0.09%
Device failureg 3 3 0.14%
Impedance NOS 3 3 0.14%
Change in sensation of stimulationh 2 1 0.05%
Therapeutic productive ineffectivei 2 1 0.05%
Back disorderj 1 1 0.05%
Broken bond wire 1 1 0.05%
Paraesthesiak 1 1 0.05%
Total 447 219 9.90%

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=43)
d Includes 6 events reported as electrodes out of range, 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, 1 lead with pinched outer insulation, 1 separation of the material on the end of the neuroelectrode, 1 broken recharger strap, 1 broken recharge belt, 1 antenna was not working, 1 lead damaged contacts, and 1 unknown problem with an extension
e Patient was unable to recharge due to device related issue (includes 6 issues with external devices)
f Includes 2 events reported as impedance not measurable, 1 antenna malfunction, 1 increased lead impedance, 1 malfunction of the spinal cord stimulation system, 1 device malfunction: problems with reprogramming
g Includes 1 broken jack and antenna, 1 failure of lead electrodes, 1 extension failure
h Includes 2 events reported as lead lost all capability of stimulation
i Includes 2 events reported as loss of paraesthesia to bilateral lower extremities due to a lead related issue.
j Physician reported they were unable to program SCS leads due to pressure in back when device was on
k Physician reported shocking sensation at battery/extension connection

A total of 406 (90.8%) of the 447 product performance events were related to the lead, 16 (3.6%) were related to the extension, 11 (2.5%) were related to an external device, 7 (1.6%) were related to the stimulator, 3 (0.7%) were related to programming/stimulation, 2 (0.4%) were related to recharging process, 1 (0.2%) was related to incisional site/device tract, and 1 (0.2%) was related to other etiology.

Neurostimulation System Non-Product Performance Events (including adverse events and device events, excluding deaths)
Eventsa Number of Non-Product Performance Events
Neurostimulator expected battery depletion 270
Implant site pain 93
Therapy non-responder 61
Implant site infection 56
Undesirable change in stimulationb 40
Recharging unable to rechargec 35
Therapeutic product ineffective 34
Change in sensation of stimulationb 32
Pain 30
Neurostimulator migration 20
Implant site erosion 11
Implant site erythema 11
Implant site effusion 9
Medical device complicationd 8
Paraesthesia 6
Wound dehiscence 6
Infection 5
Lead migration/dislogmente 5
Otherf 73
Total 805

a MedDRA Preferred Term
b Event 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 inability to activate neurostimulation not due to neurostimulator, 1 ‘POR’ alarm noted on patient’s programmer that resolved with POR, 1 prominent protrusion of the neuroelectrodes and bifurcated connectors in the left flank, 1 ERI occurred, 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
e Etiology was reported as something other than lead related. Sites have been queried for clarification.
f Composed of 45 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 65 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, 55.4% of patient deaths occurred in patients receiving therapy for pain indications in the unspecified “other” category, 38.5% for failed back, and 6.2% for CRPS.

Death by Primary Indication
Primary Indication N (%)
CRPS 4 (6.2%)
Failed Back 25 (38.5%)
Other 36 (55.4%)
Total 65 (100%)

Spinal Cord Stimulators

From June 2004 to the report cut-off date of July 31, 2012, 2542 spinal cord stimulators were followed in the Implantable Systems Performance Registry (ISPR). The difference between the total number of patients (n=2,210) versus spinal cord stimulators is due to the fact that some patients had multiple spinal cord stimulators or were subsequently re-implanted.

Over twenty percent (20.6%) of the spinal cord stimulators were RestoreUltra, 20.1% were PrimeAdvanced, 18.1% were Synergy, 17.6% were Restore, 12.0% were RestoreAdvanced, 4.1% were Itrel 3, 2.9% were RestoreSensor, and a smaller number were RestorePrime (2.2%), Synergy Versitrel (1.5%), SynergyPlus+ (0.9%), and there was 1 other unspecified model. The aggregate prospective follow-up time for all spinal cord stimulators was 48,368 months (4,031 years).

Spinal Cord Stimulator Events Spinal Cord Stimulator Events

There were 7 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 132/632 (21%). 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 7 spinal cord stimulator events was confirmed by Medtronic RPA as a broken bond wire. The remaining 6 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 (n=3), device malfunction (n=2), 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. In addition to the 7 stimulators which were cut-off due to product performance-related events, there were 1,131 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 1,404 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. 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 103
Neurostimulators Currently Active in Study 5
Device Events 0
Cumulative Months of Follow-up 2,077
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
1 yr 100.0% 60
2 yrs 100.0% 45
3 yrs 100.0% 27
at 42 mo 100.0% 20

 

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 460
Neurostimulators Currently Active in Study 35
Device Events 3
Cumulative Months of Follow-up 10,607
Neurostimulator Event Total
Undesirable change in stimulation 2
Broken bond wire 1
Total Neurostimulator Events 3
Time Interval Survival Effective Sample Size
1 yr 100.0% 267
2 yrs 99.6% 212
3 yrs 99.6% 143
4 yrs 98.9% 83
5 yrs 97.5% 47
6 yrs 97.5% 31
at 81 mo 97.5% 22

 

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

A survival curve is not shown because fewer than 20 devices had at least 24 months of follow-up at the time of the report cut-off. See tables below for more information.

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 56
Neurostimulators Currently Active in Study 8
Device Events 0
Cumulative Months of Follow-up 1,301
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
1 yr 100.0% 43
2 yrs 100.0% 23
at 30 mo 100.0% 20

 

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 512
Neurostimulators Currently Active in Study 211
Device Events 1
Cumulative Months of Follow-up 6,309
Neurostimulator Event Total
Undesirable change in stimulation 1
Total Neurostimulator Events 1
Time Interval Survival Effective Sample Size
1 yr 99.7% 238
2 yrs 99.7% 96
3 yrs 99.7% 32
at 42 mo 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 99
Device Events 1
Cumulative Months of Follow-up 12,034
Neurostimulator Event Total
Recharging unable to recharge 1
Total Neurostimulator Events 1
Time Interval Survival Effective Sample Size
1 yr 100.0% 315
2 yrs 100.0% 229
3 yrs 100.0% 145
4 yrs 100.0% 88
5 yrs 100.0% 60
6 yrs 97.1% 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 Stimulation 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 304
Neurostimulators Currently Active in Study 131
Device Events 0
Cumulative Months of Follow-up 5,865
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
1 yr 100.0% 175
2 yrs 100.0% 112
3 yrs 100.0% 63
4 yrs 100.0% 39
at 54 mo 100.0% 24

 

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 Stimulation 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 524
Neurostimulators Currently Active in Study 277
Device Events 2
Cumulative Months of Follow-up 7,454
Neurostimulator Event Total
Device malfunctiona 2
Total Neurostimulator Events 2

a One event reported as malfunction of the spinal cord stimulation system and 1 as problems with reprogramming

Time Interval Survival Effective Sample Size
1 yr 100.0% 275
2 yrs 98.6% 129
3 yrs 98.6% 50
at 42 mo 98.6% 20

 

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 Stimulation Events

A survival curve is not shown because fewer than 20 devices had at least 24 months of follow-up at the time of the report cut-off. See tables below for more information.

Spinal Cord Stimulator Characteristics
Model Name RestoreSensor
FDA Approval Date Nov 2011
Neurostimulators Enrolled 73
Neurostimulators Currently Active in Study 70
Device Events 0
Cumulative Months of Follow-up 66
Neurostimulator Event Total
Total Neurostimulator Events 0
Time Interval Survival Effective Sample Size
at 3 mo 100.0% 43

 

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
Events
Cumulative
Months of
Follow-up
Primary Cell Neurostimulators
Itrel 3 Itrel 3 Aug
1995
103 5 0 2,077
Synergy Synergy Nov
1999
460 35 3 10,607
Synergy
Versitrel
Synergy Dec
2001
38 1 0 737
Restore
Prime
Restore Mar
2006
56 8 0 1,301
Prime
Advanced
Prime
Advanced
Jul
2006
512 211 1 6,309
Rechargeable Neurostimulators
Restore Restore Apr
2005
447 99 1 12,034
Restore
Advanced
Restore Jul
2006
304 131 0 5,865
Restore
Ultra
Restore Jan
2008
524 277 2 7,454
Restore
Sensor
Restore Nov
2011
73 70 0 66
Device Survival Probability (95% Confidence Interval)
Model Name 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs
Primary Cell Neurostimulators
Itrel 3 100.0%
NA
100.0%
NA
100.0%
NA
- - -
Synergy 100.0%
NA
99.6%
(98.9%, 100.0%)
99.6%
(98.9%, 100.0%)
98.9%
(97.2%, 100.0%)
97.5%
(94.3%, 100.0%)
97.5%
(94.3%, 100.0%)
Synergy Versitrel 100.0%
NA
- - - - -
RestorePrime 100.0%
NA
100.0%
NA
- - - -
PrimeAdvanced 99.7%
(99.0%, 100.0%)
99.7%
(99.0%, 100.0%)
99.7%
(99.0%, 100.0%)
- - -
Rechargeable Neurostimulators
Restore 100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
97.1%
(91.4%, 100.0%)
RestoreAdvanced 100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
- -
RestoreUltra 100.0%
NA
98.6%
(96.6%, 100.0%)
98.6%
(96.6%, 100.0%)
- - -
RestoreSensor - - - - - -

Leads

From June 2004 to the report cut-off date of July 31, 2012, there were 4,401 leads followed in the Implantable Systems Performance Registry (ISPR). Differences between the total number of leads versus spinal cord stimulators (n=2,542) 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). More than eighty-nine percent (89.2%) of leads in the ISPR were percutaneous leads (3,927/4,401) including 55.1% (2,425/4,401) in the Pisces-Octad lead family, 28.3% (1,247/4,401) in the Pisces-Quad lead family, and 5.8% (255/4,401) in the Pisces-Quad LZ lead family. Ten percent (9.7%) of leads (426/4,401) were surgical leads. A small number of leads (48/4,401) were designated as Other (1.1%). The aggregate prospective follow-up time for all leads was 90,576 months (7,548 years).

Lead EventsLead Events

There were 406 product performance-related events with an underlying reported etiology related to the lead. Of these events, the majority were lead migration/dislodgements (n=240), high impedance (n=46), undesirable change in stimulation (n=43), or lead fracture (n=41). Of the 406 events, 358 were the first event attributable to an enrolled lead. There were 340 events in 3,927 (8.7%) percutaneous leads and 18 events in 426 (4.2%) 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 358 leads which were cut-off due to product performance-related events there were 1,343 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 2,700 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. Currently, the 95% confidence intervals for all surgical lead models overlap, indicating that survival from lead-related events is not significantly different between the surgical lead models across various applicable follow-up time points.

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, indicating that Model 3891 may not perform as well as other percutaneous lead models. As of February 6, 2008, Medtronic has discontinued worldwide distribution of the Pisces-Quad LZ lead (Models 3890, 3891, and 3892) due to performance relative to other percutaneous leads and minimal commercial demand for the product.

         
   

Model 3487A Pisces-Quad: Survival from Lead Events

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

Model 3487A: Survival from Lead Events

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Lead Characteristics
Model Number 3487A
FDA Approval Date May 1988
Leads Enrolled 774
Leads Currently Active in Study 342
Device Events 87
Cumulative Months of Follow-up 20,235
Lead Event Total
High impedance 29
Lead migration/dislodgment 23
Undesirable change in stimulation 17
Lead fracture 8
Medical device complicationa 5
Low impedance 3
Impedance NOS 2
Total Lead Events 87

a 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 91.9% 401
2 yrs 89.2% 304
3 yrs 85.7% 217
4 yrs 80.8% 172
5 yrs 78.6% 128
6 yrs 73.1% 91
7 yrs 69.9% 68
8 yrs 69.9% 43
9 yrs 69.9% 39
10 yrs 64.8% 28
at 123 mo 64.8% 24

 

Model 3487A Pisces-Quad: Specifications

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

Model 3887 Pisces-Quad: Survival from Lead Events

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

Model 3887 Pisces-Quad: Survival from Lead Events

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Lead Characteristics
Model Number 3887
FDA Approval Date Jan 1997
Leads Enrolled 145
Leads Currently Active in Study 32
Device Events 11
Cumulative Months of Follow-up 4,411
Lead Event Total
Lead fracture 7
Undesirable change in stimulation 2
Lead migration/dislodgment 1
Medical device complicationa 1
Total Lead Events 11

a Reported as lead damaged contacts

Time Interval Survival Effective Sample Size
1 yr 96.8% 72
2 yrs 88.8% 58
3 yrs 88.8% 58
4 yrs 87.1% 43
5 yrs 84.5% 36
6 yrs 82.1% 36
7 yrs 82.1% 23

 

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 328
Leads Currently Active in Study 70
Device Events 19
Cumulative Months of Follow-up 6,723
Lead Event Total
Lead migration/dislodgment 16
Undesirable change in stimulation 2
Lead fracture 1
Total Lead Events 19
Time Interval Survival Effective Sample Size
1 yr 95.4% 127
2 yrs 93.7% 76
3 yrs 88.3% 67
4 yrs 87.0% 62
5 yrs 83.8% 50
6 yrs 79.1% 34
7 yrs 79.1% 23
at 90 mo 79.1% 21

 

Model 3888 Pisces-Quad: Specifications

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

Model 3890 Pisces-Quad LZ: Survival from Lead Events

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

Model 3890 Pisces-Quad LZ: Survival from Lead Events

View Larger Image

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 20
Device Events 6
Cumulative Months of Follow-up 3,124
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% 53
2 yrs 97.0% 67
3 yrs 90.0% 52
4 yrs 90.0% 35
5 yrs 90.0% 25
at 63 mo 90.0% 21

 

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 110
Leads Currently Active in Study 7
Device Events 28
Cumulative Months of Follow-up 2,086
Lead Event Total
Lead migration/dislodgment 16
Lead fracture 6
Undesirable change in stimulation 4
Medical device complicationa 2
Total Lead Events 28

a 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 138
Leads Currently Active in Study 55
Device Events 3
Cumulative Months of Follow-up 2,182
Lead Event Total
Lead migration/dislodgement 2
Undesirable change in stimulation 1
Total Lead Events 3
Time Interval Survival Effective Sample Size
1 yr 97.3% 58
2 yrs 97.3% 38
3 yrs 97.3% 29
at 42 mo 97.3% 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 638
Leads Currently Active in Study 190
Device Events 39
Cumulative Months of Follow-up 12,291
Lead Event Total
Lead migration/dislodgment 28
Undesirable change in stimulation 7
Medical device complicationa 2
High impedance 1
Lead fracture 1
Total Lead Events 39

a Reported as damaged leads

Time Interval Survival Effective Sample Size
1 yr 93.8% 367
2 yrs 90.4% 215
3 yrs 90.4% 126
4 yrs 90.4% 70
5 yrs 88.9% 46
6 yrs 88.9% 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 1,649
Leads Currently Active in Study 828
Device Events 146
Cumulative Months of Follow-up 25,345
Lead Event Total
Lead migration/dislodgment 123
Lead fracture 7
Medical device complicationa 4
Undesirable change in stimulation 4
Change in sensation of stimulation 2
High impedance 2
Back disorder 1
Device malfunctionb 1
Impedance NOS 1
Low impedance 1
Total Lead Events 146

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

Time Interval Survival Effective Sample Size
1 yr 90.9% 797
2 yrs 87.0% 436
3 yrs 85.5% 254
4 yrs 84.8% 121
5 yrs 83.4% 52
at 66 mo 83.4% 27

 

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 84
Leads Currently Active in Study 36
Device Events 6
Cumulative Months of Follow-up 1,954
Lead Event Total
High impedance 4
Undesirable change in stimulation 2
Total Lead Events 6
Time Interval Survival Effective Sample Size
1 yr 92.1% 46
2 yrs 92.1% 30
3 yrs 88.7% 22
at 45 mo 88.7% 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 126
Leads Currently Active in Study 22
Device Events 8
Cumulative Months of Follow-up 2,737
Lead Event Total
Lead fracture 3
High impedance 2
Device failurea 1
Lead migration/dislodgment 1
Undesirable change in stimulation 1
Total Lead Events 8

a Reported as failure of lead electrodes

Time Interval Survival Effective Sample Size
1 yr 97.0% 60
2 yrs 93.3% 43
3 yrs 90.3% 26
at 39 mo 90.3% 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 103
Leads Currently Active in Study 56
Device Events 1
Cumulative Months of Follow-up 1,588
Lead Event Total
Lead migration/dislodgment 1
Total Lead Events 1
Time Interval Survival Effective Sample Size
1 yr 98.6% 58
2 yrs 98.6% 32
at 30 mo 98.6% 20

 

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 3
Device Events 2
Cumulative Months of Follow-up 1,011
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

Currently, survival from lead-related events is not statistically significantly different between surgical lead models across all applicable follow-up time points. The data indicate that Model 3891 does not perform as well as several other percutaneous lead models at 1 and 2 years of follow-up. 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 774 342 87 20,235
3887 Pisces-Quad Jan 1997 145 32 11 4,411
3888 Pisces-Quad Nov 1992 328 70 19 6,723
3890 Pisces-Quad LZ Sep 2002 128 20 6 3,124
3891 Pisces-Quad LZ Sep 2002 110 7 28 2,806
3776 Pisces-Octad Nov 2005 138 55 3 2,182
3777 Pisces-Octad Apr 2005 638 190 39 12,291
3778 Pisces-Octad Apr 2005 1,649 828 146 25,345
Surgical Leads
3986A Resume TL Apr 1995 84 36 6 1,954
3998 Specify Feb 1998 126 22 8 2,737
3999 2 x 4 Hinged Specify Jun 2004 51 3 2 1,011
39565 Specify Jun 2007 103 56 1 1,588

a There were a total of 406 lead-related events reported to the ISPR, but only 356 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=2) or were subsequent or unlinked device events that did not affect the survival estimates.

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 91.9%
(89.4%, 94.4%)
89.2%
(86.2%, 92.1%)
85.7%
(82.1%, 89.3%)
80.8%
(76.4%, 85.2%)
78.6%
(73.8%, 83.5%)
3887 Pisces-Quad 96.8%
(92.2%, 100.0%)
88.8%
(81.4%, 96.3%)
88.8%
(81.4%, 96.3%)
87.1%
(78.9%, 95.2%)
84.5%
(75.2%, 93.9%)
3888 Pisces-Quad 95.4%
(92.2%, 98.6%)
93.7%
(89.7%, 97.7%)
88.3%
(81.9%, 94.7%)
87.0%
(80.2%, 93.8%)
83.8%
(75.8%, 91.7%)
3890 Pisces-Quad LZ 100.0%
NA
97.0%
(92.8%, 100.0%)
90.0%
(82.2%, 97.8%)
90.0%
(82.2%, 97.8%)
90.0%
(82.2%, 97.8%)
3891 Pisces-Quad LZ 80.1%
(71.5%, 88.7%)
77.2%
(68.0%, 86.5%)
- - -
3776 Pisces-Octad 97.3%
(94.3%, 100.0%)
97.3%
(94.3%, 100.0%)
97.3%
(94.3%, 100.0%)
- -
3777 Pisces-Octad 93.8%
(91.6%, 96.1%)
90.4%
(87.4%, 93.5%)
90.4%
(87.4%, 93.5%)
90.4%
(87.4%, 93.5%)
88.9%
(84.6%, 93.2%)
3778 Pisces-Octad 90.9%
(89.3%, 92.6%)
87.0%
(84.8%, 89.2%)
85.5%
(82.9%, 88.0%)
84.8%
(81.9%, 87.6%)
83.4%
(79.4%, 87.3%)
Surgical Leads
3986A Resume TL 92.1%
(85.3%, 98.9%)
92.1%
(85.3%, 98.9%)
88.7%
(79.3%, 98.0%)
- -
3998 Specify 97.0%
(92.8%, 100.0%)
93.3%
(86.8%, 99.8%)
90.3%
(81.6%, 99.0%)
- -
3999 2 x 4 Hinged Specify 96.7%
(90.3%, 100.0%)
93.6%
(84.7%, 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 10 yrs
Percutaneous Leads
3487A Pisces-Quad 73.1%
(67.1%, 79.2%)
69.9%
(63.1%, 76.7%)
69.9%
(63.1%, 76.7%)
69.9%
(63.1%, 76.7%)
64.8%
(55.4%, 74.2%)
3887 Pisces-Quad 82.1%
(71.9%, 92.4%)
82.1%
(71.9%, 92.4%)
- - -
3888 Pisces-Quad 79.1%
(69.2%, 89.0%)
79.1%
(69.2%, 89.0%)
- - -
3890 Pisces-Quad LZ - - - - -
3891 Pisces-Quad LZ - - - - -
3776 Pisces-Octad - - - - -
3777 Pisces-Octad 88.9%
(84.6%, 93.2%)
- - - -
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, 2012, there were 2,486 extensions followed in the Implantable Systems Performance Registry (ISPR). Differences between the total number of extensions versus spinal cord stimulators (n=2,542) 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-five percent (35.8%) of the extensions were Model 37081 extensions, 27.3% were Model 7489 extensions, 20.0% were Model 37082 extensions, 8.0% were Model 7495 extensions, 7.4% 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 51,058 months (4,255 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. In addition to the 15 extensions which were cut-off due to product performance-related events there, were 1,026 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 1,445 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 Extension Family: Survival from Extension Events

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

Model 7489 Extension Family: Survival from Extension Events

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Extension Characteristics
Model Number 7489
FDA Approval Date Oct 2002
Extensions Enrolled 678
Extensions Currently Active in Study 77
Device Events 3
Cumulative Months of Follow-up 15,099
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% 284
2 yrs 99.6% 292
3 yrs 98.8% 217
4 yrs 98.8% 143
5 yrs 98.8% 104
6 yrs 98.8% 76
7 yrs 98.8% 51
at 93 mo 98.8% 25

 

Model 7489 Extension Family: Specifications

Device Name Low Profile Quad Extension ppr-7489
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.

Model 37081 Extension Family: Survival from Extension Events

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Extension Characteristics
Model Number 37081
FDA Approval Date Apr 2005
Extensions Enrolled 889
Extensions Currently Active in Study 318
Device Events 5
Cumulative Months of Follow-up 15,423
Extension Event Total
Extension fracture 5
Total Extension Events 5
Time Interval Survival Effective Sample Size
1 yr 99.8% 494
2 yrs 99.3% 301
3 yrs 98.4% 157
4 yrs 98.4% 66
5 yrs 98.4% 28
at 63 mo 98.4% 24

 

Model 37081 Extension Family: Specifications

Device Name 1x8 Extension ppr-37081
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.

Model 37082: Extension Family Survival from Extension Events

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Extension Characteristics
Model Number 37082
FDA Approval Date Mar 2006
Extensions Enrolled 498
Extensions Currently Active in Study 207
Device Events 3
Cumulative Months of Follow-up 9,986
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% 309
2 yrs 99.1% 190
3 yrs 99.1% 92
4 yrs 99.1% 56
5 yrs 99.1% 34
at 66 mo 99.1% 21

 

37082 Extension Family: Specifications

Device Name Bifurcated Stretch-Coil Extension ppr-37082
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.

Model 37083 Extension Family: Survival from Extension Events

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Extension Characteristics
Model Number 37083
FDA Approval Date Sep 2005
Extensions Enrolled 183
Extensions Currently Active in Study 53
Device Events 4
Cumulative Months of Follow-up 3,925
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% 100
2 yrs 96.9% 84
3 yrs 95.5% 48
4 yrs 95.5% 34
5 yrs 95.5% 20

 

Model 37083 Extension Family: Specifications

Device Name Single Stretch-Coil Extension ppr-37083
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 889 318 5 15,423
37082 37082 Mar 2006 498 207 3 9,986
37083 37083 Sep 2005 183 53 4 3,925
7489 7489 Oct 2002 678 77 3 15,099

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 99.8%
(99.5%, 100.0%)
99.3%
(98.4%, 100.0%)
98.4%
(96.9%, 99.9%)
98.4%
(96.9%, 99.9%)
98.4%
(96.9%, 99.9%)
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%)
99.1%
(98.0%, 100.0%)
37083 99.0%
(96.9%, 100.0%)
96.9%
(93.4%, 100.0%)
95.5%
(91.1%, 100.0%)
95.5%
(91.1%, 100.0%)
95.5%
(91.1%, 100.0%)
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 9 yrs 10 yrs
37081 -

 
- - - -
37082 -

 
- - - -
37083 -

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

2012 Medtronic Product Performance Report: Data through July 31, 2012

United States