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Spinal Cord Stimulation Systems

Spinal Cord Stimulation Systems

Study Participants

Centers

The following spinal cord stimulation tables and graphs were generated based on data collected between June 2004 and the report cut-off date of October 31, 2017. Seventy-nine centers in North America, Europe and South America, have enrolled and contributed patient data to the spinal cord stimulation section of the report.


Patients

Of the 4,867 total spinal cord stimulation patients enrolled, 44.6% were implanted for the treatment of failed back pain, 30.2% were implanted for the treatment of other primary indications, 13.3% were implanted for the treatment of other primary indication/Radicular Pain Syndrome, 10.8% were implanted for the treatment of complex regional pain syndrome (CRPS), and 1.0% were implanted for indications that were not specified in the database.

Primary Spinal Cord Stimulation Treatment Indications Primary Spinal Cord Stimulation Treatment Indications

Primary SCS System Treatment Indications Chart
Primary Treatment Indicationa
Total Enrolled Patients (Percent)
Failed Back Pain
2,169 (44.6%)
   Post Laminectomy pain
814 (16.7%)
   Failed Back Surgery Syndrome (FBSS)
728 (15.0%)
   Combination back and leg pain
511 (10.5%)
   Multiple back operations
84 (1.7%)
   Arachnoiditis
22 (0.5%)
   Unsuccessful disc surgery
10 (0.2%)
Other Primary Indication
2,120 (43.6%)
   Other chronic pain
799 (16.4%)
   Radicular pain syndrome
648 (13.3%)
   Other Secondary Indications
313 (6.4%)
   Degenerative disc disease
205 (4.2%)
   Cervical pain
50 (1.0%)
   Traumatic nerve injury
37 (0.8%)
   Diabetic neuropathy
29 (0.6%)
   Post herpetic neuralgia
16 (0.3%)
   Facial pain
7 (0.1%)
   Angina
5 (0.1%)
   Chronic cluster headache
4 (0.1%)
   Epidural fibrosis
4 (0.1%)
   Post herniorrhaphy pain
3 (0.1%)
CRPS
528 (10.8%)
   CRPS I
406 (8.3%)
   CRPS II
122 (2.5%)
Not Specified
50 (1.0%)
Total Patients
4,867

a Refer to product labeling for approved indications.

Event Summary

There were 1,253 product-performance events reported between June 2004 and October 31, 2017 in patients with spinal cord stimulation systems.  These events represent over thirty-six percent of the total reported events (1,253/3,450). These events occurred in 589 of the 4,867 total patients (12.10%) enrolled, and are presented graphically within this report (e.g. events per patient years as well as survival curves).

In addition, there were 2,197 non-product performance events that were collected to understand patient experience (clinical signs and symptoms) with the spinal cord stimulation systems. There were also 148 deaths reported for patients followed in the PSR with spinal cord stimulation systems, none of which were reported as a direct result of a product performance event.  Early versions of the protocol required events to be reported only when the event required a surgical intervention, resulted in therapy abandonment, or resulted in death.  The required event reporting definition was expanded in April 2010 to include all adverse events related to the device, implant procedure, and/or therapy.  The event tables provided below include combined data from these versions of the protocol.

Spinal Cord Stimulation System Product Performance Events

Event a

Number
of Product Performance Events

Number
of Patients with Event
b

Percent
of Patients with Event

(N=4,867)

   Lead migration/dislodgement

573

300

6.2%

   High impedance

317

136

2.8%

   Lead fracture

81

51

1.1%

   Battery recharge issue c

57

55

1.1%

   Device stimulation issue d

49

28

0.6%

   Low impedance

38

14

0.3%

   Device malfunction e

30

29

0.6%

   Extension fracture

17

11

0.2%

   Device breakage f

16

16

0.3%

   Medical device complication g

15

10

0.2%

   Device connection issue

6

4

0.1%

   Device telemetry issue

5

5

0.1%

   Extension migration

5

4

0.1%

   Device failure h

4

3

0.1%

   Impedance increased

4

3

0.1%

   Antenna cable breakage

4

4

0.1%

   Device battery issue

4

3

0.1%

   Device defective

4

4

0.1%

   Device component issue i

3

3

0.1%

   Device difficult to use

3

3

0.1%

   Device electrical impedance issue

2

2

0.04%

   Impedance decreased

2

1

0.02%

   Inadequate lead connection

2

1

0.02%

   Paraesthesia j

2

2

0.04%

   Therapeutic product ineffective

2

1

0.02%

   Device electrical impedance issue

2

2

0.04%

   Broken bond wire

1

1

0.02%

   Device kink

1

1

0.02%

   Device loosening

1

1

0.02%

   Grommet loose

1

1

0.02%

   Lead insulation failure

1

1

0.02%

   Medical device site pain k

1

1

0.02%

Totals

1,253

589

12.10%

a Medical Dictionary for Regulatory Activities (MedDRA) Lower-LevelTerm or Medtronic’s coding system term for events that do not exist in the MedDRA dictionary.
b The total number of patients may not represent the sum of all rows, as a patient may have experienced more than one type of event.
c There were a total of 3,248 patients that used rechargeable SCS neurostimulators in the registry. A total of 1.8% (57/3,248) of patients with a rechargeable SCS neurostimulator experienced a neurostimulator unable to recharge or battery recharge issue product performance event.
d Device stimulation issue reported by physician as being caused by neurostimulator (n=2) or lead (n=45) or programming (2).
e Includes 6 charger malfunctions, 5 neurostimulator malfunctions, 3 patient recharger not working, 3 antenna malfunctions, 2 inability to turn neurostimulator on, 2 events for non-functional lead electrodes, 2 contacts not working, 3 malfunctioning programmer, 1 programmer reporting error message, 1 stimulator turning off and on, 1 SCS stopped abruptly, and 1 recharging cable malfunction.
f Includes 6 broken charger belts, 1 broken recharger strap, 3 broken chargers, 2 broken patient programmer, 1 frayed cord to charger antenna, 1 broken charger cord, 1 broken component of patient programmer and 1 frayed wire to charger.
g Includes 4 leads no longer providing stimulation, 4 error messages on patient programmer, 2 unable to pass stylet into lead, 2 leads with open circuits, 1 unknown problem with extension, 1 excessive heating of charging unit and 1 unknown programmer error message
h Includes 2 events for lead failure, 1 event for failure of lead electrodes, and 1 extension failure.
i Includes 1 event for damaged antenna cord, I extension stuck in IPG, and 1 faulty antenna.
j Includes 1 event for shocking sensation at battery site and 1 shocking sensation at battery/extension connection.
k Event reported by site has been queried.

A total of 1,001(79.9%) of the 1,253 product performance events were related to the lead, 68 (5.4%) were related to “other device”, 51 (4.1%) were related to the neurostimulator, 48 (3.8%) were related to “multiple etiologies”, which includes events where at least one device and one non-device etiology was indicated, 35 (2.8%) were related to the extension, 31 (2.5%) were related to the recharging process, 7 (0.6%) were related to programming/stimulation, 5 (0.4%) were related to “other” etiology, 4 (0.3%) were related to the incisional site/device tract, and 3 (0.2%) were related to surgery/anesthesia. Relatedness is determined by the physician.

Product Performance Events by Relatednessa 

Product Performance Events by Relatedness

a Each event could have more than one etiology.

Events not-related to a product-performance issue are characterized below. Due to the differences in event collection between the ISPR and PSR protocols, events per patient years and other rates are not calculated for non-product performance events.

Events are categorized by an event group term as noted in bold in the table below.

 

Spinal Cord Stimulation System Non-Product Performance Events
(including adverse eventsa and device events, excluding deaths and normal battery depletions)

Events b

Number of Non-Product Performance Events

Device issues

654

   Device stimulation issue c

310

   Battery recharge issue d

187

   Device battery issue e

47

   Neurostimulator migration

31

   Neurostimulator inversion

21

   Device malfunction f

15

   Device extrusion

5

   Other g

30

Therapeutic and nontherapeutic effects (excluding toxicity)

476

   Therapeutic product ineffective

272

   Therapeutic response decreased

143

   Therapy non-responder

56

   Other g

5

Complications associated with device

327

   Medical device site pain

200

   Medical device discomfort

21

   Medical device site erythema

19

   Medical device site extravasation

16

   Medical device site erosion

13

   Medical device site discomfort

9

   Medical device site burn

7

   Medical device site irritation

6

   Medical device complication

5

   Other g

31

Infections - pathogen unspecified

154

   Medical device site infection

117

   Wound infection

18

   Infection

13

   Other g

6

General system disorders Not Elsewhere Classified (NEC)

135

   Pain

116

   No anomaly found by RPA h

19

   Other g

8

Procedural related injuries and complications NEC

102

   Inadequate analgesia

29

   Incision site pain

16

   Incision site erythema

13

   Wound dehiscence

12

   Seroma

7

   Suture related complication

6

   Other g

19

Musculoskeletal and connective tissue disorders NEC

82

   Pain in extremity

34

   Back pain

31

   Musculoskeletal pain

7

   Musculoskeletal chest pain

6

   Other g

4

Neurological disorders NEC

68

   Paraesthesia

41

   Sensory disturbance

7

   Cerebrospinal fluid leakage

5

   Other g

15

Medication errors and other product use errors and issues

47

   Device difficult to use

35

   Device use error

8

   Other g

4

Muscle disorders

17

   Muscle spasms

13

   Other g

4

Injuries NEC

16

   Wound secretion

6

   Other g

10

Spinal cord and nerve root disorders

16

   Radiculopathy

14

   Other g

2

Headaches

15

   Headache

13

   Other g

2

Epidermal and dermal conditions

14

   Other g

14

Administration site reactions

11

   Other g

11

Bacterial infectious disorders

10

   Other g

10

Tissue disorders NEC

10

   Impaired healing

10

Allergic conditions

7

   Hypersensitivity

6

   Other g

1

Anxiety disorders and symptoms

6

   Other g

6

Gastrointestinal signs and symptoms

6

   Other g

6

Other

24

Total

2197

a Adverse events associated with product performance events are not included in this table. Related adverse and device events reported on a single event form are represented individually in this table.
b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms.
c Event reported by the physician with an etiology that was either not device related or had no associated device event.
d Events reported as recharge issues not due to a device malfunction.
e Events reported as battery discharge or depletion not due to a device malfunction.
f Events were device issues due to patient use or other non-device defect etiology.
g Comprised of event codes with fewer than 5 events each.
h For products that are returned with a suspected device issue, and RPA establishes a root cause or finds no anomaly, results reported herein reflect the finding from Returned Product Analysis (RPA).

There were 148 deaths reported for patients with spinal cord stimulation systems, none of which were reported as a direct result of a product performance event. As indicated, 75 (50.68%) of the deaths occurred in patients receiving therapy for pain indications in the “other” category, 62 (41.89%) for failed back, and 11 (7.43%) for CRPS.

Number of Reports of Death by Primary Indication
Primary Indicationa
N (% of deaths)
Other
75 (50.68%)
Failed Back
62 (41.89%)
CRPS
11 (7.43%)
Total
148 (100%)

a Refer to product labeling for approved indications

Neurostimulators


From June 2004 to the report cut-off date of October 31, 2017, 5,305 spinal cord neurostimulators were followed in the registry.  The difference between the total number of patients (N=4,867) versus neurostimulators is due to the fact that some patients had multiple neurostimulators or were subsequently re-implanted. The aggregate prospective follow-up time for all spinal cord neurostimulators was 105,174 months (8,765 years). The table below provides the number and percentage of spinal cord neurostimulators by model.

Spinal Cord Neurostimulators by Model

Model

Number of Neurostimulators (%)

RestoreSensor SureScan MRI (97714)

1,291 (24.3%)

PrimeAdvanced (37702)

671 (12.6%)

PrimeAdvanced SureScan MRI (97702)

579 (10.9%)

RestoreSensor (37714)

378 (7.1%)

RestoreAdvanced (37713)

357 (6.7%)

RestoreAdvanced SureScan MRI (97713)

113 (2.1%)

Itrel 4 (37703)

88 (1.7%)

RestoreUltra SureScan MRI (97712)

80 (1.5%)

Other/Unspecified

19 (0.4%)

Intellis with AdaptiveStim (97715)

9 (0.2%)

Neurostimulators No Longer Manufactured

RestoreUltra (37712)

581 (11.0%)

Synergy (7427)

461 (8.7%)

Restore (37711)

448 (8.4%)

Itrel 3 (7425)

96 (1.8%)

RestorePrime (37701)

57 (1.1%)

Synergy Versitrel (7427V)

53 (1.0%)

Synergy Plus (7479)

16 (0.3%)

Synergy Compact (7479B)

8 (0.2%)

Total

5,305 (100%)

Neurostimulator Events Neurostimulator Events

There were 61 product performance-related events with an underlying reported etiology related to spinal cord neurostimulator function. This includes 51 events with a neurostimulator etiology and 10 events with both a neurostimulator and other etiology (including device and non-device etiologies). Of these, 56 were the initial product performance event that affected neurostimulator survival estimates.  For spinal cord neurostimulators in the registry, the current return rate to Medtronic Returned Product Analysis (RPA) was 316/1,337 (24%).  The proportion was based upon the number of registry spinal cord neurostimulators received by RPA, divided by the total number of explanted devices plus the total number of neurostimulators in patients who have expired. Two of the 61 spinal cord neurostimulator events was confirmed by Medtronic RPA as a broken bond wire and a loose grommet. The neurostimulators with the remaining 59 performance-related events were not returned to Medtronic RPA and the events were assigned as device related by the physician. These events included: neurostimulator unable to recharge (n=16), high impedance (n=16), device malfunction (n=7),  lead migration/dislodgement (n=4), battery recharge issue (n=4), medical device complication (n=3), device stimulation issue (n=2), low impedance (n=2), device difficult to use (n=1), neurostimulator migration (n=1), device connection issue (n=1), device battery issue (n=1),  and device telemetry issue (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 censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off.  For spinal cord neurostimulators:

  • 56 had follow-up time cut-off due to product performance-related events.
  • 3,542 were censored in the survival analysis for the following reasons: patient expired, neurostimulator explanted, patient discontinued, therapy suspended, or site discontinued participation in the registry.
  • 1,707 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Neurostimulator SurvivalNeurostimulator Survival

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

                                                                             

Model 7425 Itrel 3: Survival from Spinal Cord Neurostimulator Events

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

Model 7425 Itrel 3: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
Itrel 3
FDA Approval Date
Aug 1995
Neurostimulators Enrolled
96
Neurostimulators Currently Active in Study
0
Device Events
0
Cumulative Months of Follow-up
1,457
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100.0%
(NA)
35
2 yrs
100.0%
(NA)
26
at 33 mo
100.0%
(NA)
20

Model 7425 Itrel 3: Specifications

Height 2.2 in (55 mm) ppr-8627-18
Width 2.4 in (60 mm)
Thickness 0.4 in (10 mm)
Volume 22 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use
Maximum Electrodes 4
Amplitude 0 - 10.5 V
Rate 2.1 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 1
Programs 1
Implant Depth ≤ 4 cm

Model 37703 Itrel 4: Survival from Spinal Cord Neurostimulator Events

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

Model 37703 Itrel 4: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
Itrel 4
FDA Approval Date
May 2012
Neurostimulators Enrolled
88
Neurostimulators Currently Active in Study
67
Device Events
2
Cumulative Months of Follow-up
1609
Model 37703 Itrel 4: Event Summary Table
Neurostimulator Event
Total
High impedance
1
Device malfunction
1
Total Neurostimulator Events
2
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
98.6%  (90.2%, 99.8%)
59
at 27 mo
96.7% (87.2%, 99.2%)
30

Model 37703 Itrel 4: Specifications

Height 2.2 in (55 mm) ppr-itrel4
Width 2.4 in (60 mm)
Thickness 0.4 in (11 mm)
Volume 28 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use
Maximum Electrodes 4
Amplitude 0 - 10.5 V
Rate 2 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 1
Programs 1
Implant Depth ≤ 4 cm

 

Model 7427 Synergy: Survival from Spinal Cord Neurostimulator Events

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

Model 7427 Synergy: Survival from Spinal Cord Stimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
Synergy
FDA Approval Date
Nov 1999
Neurostimulators Enrolled
461
Neurostimulators Currently Active in Study
3
Device Events
3
Cumulative Months of Follow-up
9,820
Model 7427 Synergy: Event Summary Table
Neurostimulator Event
Total
Broken bond wire
1
Device connection issue
1
Device stimulation issue
1
Total Neurostimulator Events
3
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100.0%
(NA)
210
2 yrs
99.5%
(96.6%, 99.9%)
178
3 yrs
99.5%
(96.6%, 99.9%)
123
4 yrs
98.7%
(94.5%, 99.7%)
81
5 yrs
97.4%
(91.5%, 99.2%)
48
6 yrs
97.4%
(91.5%, 99.2%)
34
7 yrs
97.4%
(91.5%, 99.2%)
23
8 yrs
97.4%
(91.5%, 99.2%)
21

Model 7427 Synergy: Specifications

Height 2.4 in (61 mm) ppr-7427
Width 3.0 in (76 mm)
Thickness 0.6 in (15 mm)
Volume 51 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use
Maximum Electrodes 8
Amplitude 0 - 10.5 V
Rate 3 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 1
Programs 2
Implant Depth ≤ 4 cm

Model 37701 RestorePrime: Survival from Spinal Cord Neurostimulator Events

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

Model 37701 RestorePrime: Survival from Spinal Cord Stimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
RestorePrime
FDA Approval Date
Mar 2006
Neurostimulators Enrolled
57
Neurostimulators Currently Active in Study
1
Device Events
0
Cumulative Months of Follow-up
1,305
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100.0%
(NA)
38
2 yrs
100.0%
(NA)
24
at 27 mo
100.0%
(NA)
22

Model 37701 RestorePrime: Specifications

Height 2.6 in (65 mm) ppr-37701
Width 1.9 in (49 mm)
Thickness 0.6 in (15 mm)
Volume 39 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 4
Implant Depth ≤ 4 cm

Model 37702 PrimeAdvanced: Survival from Spinal Cord Neurostimulator Events

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

Model 37702 PrimeAdvanced: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
PrimeAdvanced
FDA Approval Date
Jul 2006
Neurostimulators Enrolled
671
Neurostimulators Currently Active in Study
67
Device Events
6
Cumulative Months of Follow-up
13,760
Model 37702 PrimeAdvanced: Event Summary Table

Neurostimulator Event

Total

High impedance

2

Battery recharge issue

1

Device malfunction a

1

Device stimulation issue

1

Low impedance

1

Total Neurostimulator Events

6

a Reported as suspected device malfunction.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.6%
(98.5%, 99.9%)
390
2 yrs
99.3%
(97.9%, 99.8%)
230
3 yrs
98.8%
(96.5%, 99.6%)
123
4 yrs
97.7%
(93.4%, 99.2%)
68
5 yrs

97.7%
(93.4%, 99.2%)

32
at 66 mo
97.7%
(93.4%, 99.2%)
27

Model 37702 PrimeAdvanced: Specifications

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

Model 37711 Restore: Survival from Spinal Cord Neurostimulator Events

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

Model 37711 Restore: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
Restore
FDA Approval Date
Apr 2005
Neurostimulators Enrolled
448
Neurostimulators Currently Active in Study
4
Device Events
5
Cumulative Months of Follow-up
13,902
Model 37711 Restore: Event Summary Table

Neurostimulator Event

Total

Battery recharge issue

4

Device malfunction a

1

Total Neurostimulator Events

5

a Reported as suspected device malfunction.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100.0%
(NA)
289
2 yrs
100.0%
(NA)
234
3 yrs
100.0%
(NA)
155
4 yrs
100.0%
(NA)
99
5 yrs
100.0%
(NA)
79
6 yrs
98.5%
(89.7%, 99.8%)
59
7 yrs
98.5%
(89.7%, 99.8%)
47
8 yrs
98.5%
(89.7%, 99.8%)
35
at 105 mo
92.9%
(78.9%, 97.7%)
23

Model 37711 Restore: Specifications

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

Model 37712 RestoreUltra: Survival from Spinal Cord Neurostimulator Events

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

Model 37712 RestoreUltra: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
RestoreUltra
FDA Approval Date
Jan 2008
Neurostimulators Enrolled
581
Neurostimulators Currently Active in Study
24
Device Events
8
Cumulative Months of Follow-up
14,599
Model 37712 RestoreUltra: Event Summary Table

Neurostimulator Event

Total

Battery recharge issue

5

Device malfunction a

2

Medical device complication b

1

Total Neurostimulator Events

8

a Reported as malfunction of the spinal cord stimulation system.
b Reported as inadequate stimulation paresthesia coverage

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100%
(NA)
342
2 yrs
99.6%
(97.3%, 99.9%)
206
3 yrs
99.1%
(96.5%, 99.8%)
143
4 yrs
98.2%
(94.1%, 99.5%)
98
5 yrs
97.0%
(91.3%, 99.0%)
77
6 yrs
95.5%
(88.6%, 98.3%)
53
7 yrs
93.2%
(83.8%, 97.3%)
33
at 90 mo
89.7%
(76.3%, 95.8%)
24

Model 37712 RestoreUltra: Specifications

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

Model 37713 RestoreAdvanced: Survival from Spinal Cord Neurostimulator Events

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

Model 37713 RestoreAdvanced: Survival from Spinal Cord Neurostimulator Events

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
RestoreAdvanced
FDA Approval Date
Jul 2006
Neurostimulators Enrolled
357
Neurostimulators Currently Active in Study
30
Device Events
1
Cumulative Months of Follow-up
10,593
Model 37713 RestoreAdvanced: Event Summary Table
Neurostimulator Event
Total
Medical device complicationa
1
Total Neurostimulator Events
1

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

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.7%
(97.6%, 100.0%)
236
2 yrs
99.7%
(97.6%, 100.0%)
168
3 yrs
99.7%
(97.6%, 100.0%)
110
4 yrs
99.7%
(97.6%, 100.0%)
73
5 yrs
99.7%
(97.6%, 100.0%)
52
6 yrs
99.7%
(97.6%, 100.0%)
41
7 yrs
99.7%
(97.6%, 100.0%)
29
8 yrs
99.7%
(97.6%, 100.0%)
21
at 99 mo
99.7%
(97.6%, 100.0%)
20

Model 37713 RestoreAdvanced: Specifications

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

Model 37714 RestoreSensor: Survival from Spinal Cord Neurostimulator Events

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

Model 37714 RestoreSensor: Survival from Spinal Cord Neurostimulator Events

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Spinal Cord Neurostimulator Characteristics
Model Name
RestoreSensor
FDA Approval Date
Nov 2011
Neurostimulators Enrolled
378
Neurostimulators Currently Active in Study
116
Device Events
3
Cumulative Months of Follow-up
9,012
Model 37714 RestoreSensor: Event Summary Table
Neurostimulator Event
Total
Battery recharge issue
2
Device difficult to use
1
Total Neurostimulator Events
3
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.7%
(97.6%, 100.0%)
252
2 yrs
98.7%
(96.1%, 99.6%)
171
3 yrs
98.7%
(96.1%, 99.6%)
109
4 yrs
98.7%
(96.1%, 99.6%)
47
at 54 mo
98.7%
(96.1%, 99.6%)
26

Model 37714 RestoreSensor: Specifications

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

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

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

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

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
PrimeAdvanced SureScan MRI
FDA Approval Date
Mar 2013
Neurostimulators Enrolled
579
Neurostimulators Currently Active in Study
392
Device Events
6
Cumulative Months of Follow-up
7,776

Model 97702 PrimeAdvanced SureScan MRI: Event Summary Table

Neurostimulator Event

Total

High impedance

3

Device battery issue

1

Lead migration/dislodgement a

1

Battery recharge issue

1

Total Neurostimulator Events

6


a Reported as related to both lead and nuerostimulator.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.0%
(97.4%, 99.6%)
289
2 yrs
98.6%
(96.7%, 99.4%)
118
3 yrs
96.9%
(90.1%, 99.0%)
22

Model 97702 PrimeAdvanced SureScan MRI: Specifications

Height 2.6 in (65 mm) ppr-97702
Width 1.9 in (49 mm)
Thickness 0.6 in (15 mm)
Volume 39 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 3 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 32
Implant Depth ≤ 4 cm

 

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

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

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

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Spinal Cord Neurostimulator Characteristics
Model Name
RestoreUltra SureScan MRI
FDA Approval Date
Mar 2013
Neurostimulators Enrolled
80
Neurostimulators Currently Active in Study
48
Device Events
0
Cumulative Months of Follow-up
928
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100%
(NA)
34
at 15 mo
100%
(NA)
26

Model 97712 RESTOREULTRA SURESCAN MRI: Specifications

Height 2.1 in (54 mm) ppr-97712
Width 2.1 in (54 mm)
Thickness 0.4 in (10 mm)
Volume 22 cc
Battery type Rechargeable
Expected Battery life 9 years
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 1200 Hz
Pulse Width 60 - 1000 μsec
Groups 8
Programs 16
Implant Depth ≤ 1 cm

 

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

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

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

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
RestoreAdvanced SureScan MRI
FDA Approval Date
Mar 2013
Neurostimulators Enrolled
113
Neurostimulators Currently Active in Study
68
Device Events
1
Cumulative Months of Follow-up
1,842
Model 97713 RestoreAdvanced SureScan MRI: Event Summary Table
Neurostimulator Event
Total
Device malfunctiona
1
Total Neurostimulator Events
1

a Reported as malfunction of spinal cord neurostimulator.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
98.9%
(92.2%, 99.8%)
63
2 yrs
98.9%
(92.2%, 99.8%)
31
at 30 mo
98.9%
(92.2%, 99.8%)
22

Model 97713 RestoreAdvanced Surescan MRI: Specifications

Height 2.6 in (65 mm) ppr-97713
Width 1.9 in (49 mm)
Thickness 0.6 in (15 mm)
Volume 39 cc
Battery type Rechargeable
Expected Battery life 9 years
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 130 Hz
Pulse Width 60 - 450 μsec
Groups 26
Programs 32
Implant Depth ≤ 1 cm

 

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

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

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

View Larger Image

Spinal Cord Neurostimulator Characteristics
Model Name
RestoreSensor SureScan MRI
FDA Approval Date
Mar 2013
Neurostimulators Enrolled
1,291
Neurostimulators Currently Active in Study
875
Device Events
19
Cumulative Months of Follow-up
16,795

Model 97714 RestoreSensor SureScan MRI: Event Summary Table

Neurostimulator Event

Total

Battery recharge issue

7

High impedance

4

Lead migration/dislodgement a

3

Device telemetry issue

1

Low impedance

1

Neurostimulator migration

1

Device malfunction b

1

Grommet loose

1

Total Neurostimulator Events

19

a Reported as related to both lead and neurostimulator.
b Reported as stimulator "turning off and on" on its own.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
98.8%
(97.8%, 99.3%)
598
2 yrs
97.5%
(95.9%, 98.5%)
241
3 yrs
96.8%
(94.3%, 98.2%)
60
at 39 mo
96.8%
(94.3%, 98.2%)
41

Model 97714 RestoreSensor SureScan MRI: Specifications

Height 54 mm (2.1 in) ppr-97714
Width 54 mm (2.1 in)
Thickness 9 mm (0.4 in)
Volume 22 cc
Battery type Rechargeable
Expected Battery life 9 years
Maximum Electrodes 16
Amplitude 0 - 10.5 V
Rate 2 - 1200 Hz
Pulse Width 60 - 1000 msec
Groups 8
Programs 16
Implant Depth ≤ 1 cm

Spinal Cord Stimulator Survival Summary Spinal Cord Stimulator Survival Summary

Spinal Cord Neurostimulator Survival Summary Table
Model Name
Family
FDA
Approval
Date
Neuro-
stimulators
Enrolled
Neuro-
stimulators
Currently
Active in
Study
Device
Eventsa
Cumulative
Months of
Follow-up
Primary Cell Neurostimulators
Itrel 3
Itrel 3
Aug
1995
96
0
0
1,457
Itrel 4
Itrel 4
May
2012
88
67
2
1,609
Synergy
Synergy
Nov
1999
461
3
3
9,820
Restore
Prime
Restore
Mar
2006
57
1
0
1,305
Prime
Advanced
Prime
Advanced
Jul
2006
671
67
6
13,760
Prime
Advanced
SureScan
MRI
Prime
Advanced
Mar
2013
579
392
6
7,776
Rechargeable Neurostimulators
Restore
Restore
Apr
2005
448
4
5
13,902
Restore
Ultra
Restore
Jan
2008
581
24
8
14,599
Restore
Advanced
Restore
Jul
2006
357
30
1
10,593
Restore
Sensor
Restore
Nov
2011
378
116
3
9,012
Restore
Ultra
SureScan
MRI
Restore
Mar
2013
80
48
0
928
Restore
Advanced
SureScan
MRI
Restore
Mar
2013
113
68
1
1,842
Restore
Sensor
SureScan
MRI
Restore
Mar
2013
1,291
875
19
16,795

a There were 61 neurostimulator-related events reported to the registry, but only 54 events included in this summary table. The remaining neurostimulator related events occurred in a model for which no device survival data are presented due to an insufficient number of enrolled devices (n=2), or were subsequent events (i.e. additional events that occurred after the initial device event) that did not affect the device survival estimates. .

Device Survival Probability (95% Confidence Interval)Table 1 of 2
Model Name
1 yr
2 yrs
3 yrs
4 yrs
Primary Cell Neurostimulators
Itrel 3
100.0%
(NA)
100.0%
(NA)
-
-
Itrel 4
98.6%
(90.2%, 99.8%)
96.7%
(87.2%, 99.2%)
-
-
Synergy
100.0%
(NA)
99.5%
(96.6%, 99.9%)
99.5%
(96.6%, 99.9%)
98.7%
(94.5%, 99.7%)
RestorePrime
100.0%
(NA)
100.0%
(NA)
-
-
PrimeAdvanced
99.6%
(98.5%, 99.9%)
99.3%
(97.9%, 99.8%)
98.8%
(96.5%, 99.7%)
97.7%
(93.4%, 99.2%)
PrimeAdvanced
SureScan
MRI
99.0%
(97.4%, 99.6%)
98.6%
(96.7%, 99.4%)
96.9%
(90.1%, 99.0%)
-
Rechargeable Neurostimulators
Restore
100.0%
NA
100.0%
NA
100.0%
NA
100.0%
NA
RestoreUltra
100.0%
(NA)
99.6%
(97.3%, 99.9%)
99.1%
(96.5%, 99.8%)

98.2%
(94.1%, 99.5%)

RestoreAdvanced
99.7%
(97.6%, 100.0%)
99.7%
(97.6%, 100.0%)
99.7%
(97.6%, 100.0%)
99.7%
(97.6%, 100.0%)
RestoreSensor
99.7%
(97.6%, 100.0%)
98.7%
(96.1%, 99.6%)
98.7%
(96.1%, 99.6%)
98.7%
(96.1%, 99.6%)
RestoreUltra
SureScan MRI
100.0%
(NA)
-
-
-
RestoreAdvanced
SureScan MRI
98.9%
(92.2%, 99.8%)
98.9%
(92.2%, 99.8%)
-
-
Restore Sensor
SureScan MRI
98.8%
(97.8%, 99.3%)
97.5%
(95.9%, 98.5%)
96.8%
(94.3%, 98.2%)
-

Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Name
5 yrs
6 yrs
7 yrs
8 yrs
Primary Cell Neurostimulators
Itrel 3
-
-
-
-
Itrel 4
-
-
-
-
Synergy
97.4%
(91.5%, 99.2%)
97.4%
(91.5%, 99.2%)
97.4%
(91.5%, 99.2%)
97.4%
(91.5%, 99.2%)
RestorePrime
-
-
-
-
PrimeAdvanced
97.7%
(93.4%, 99.2%)
-
-
-
PrimeAdvanced
SureScan MRI
-
-
-
-
Rechargeable Neurostimulators
Restore
100.0%
NA
98.5%
(89.7%, 99.8%)
98.5%
(89.7%, 99.8%)
98.5%
(89.7%, 99.8%)
RestoreUltra
97.0%
(91.3%, 99.0%)
95.5%
(88.6%, 98.3%)
93.2%
(83.8%, 97.3%)
-
RestoreAdvanced
99.7%
(97.6%, 100.0%)
99.7%
(97.6%, 100.0%)
99.7%
(97.6%, 100.0%)
99.7%
(97.6%, 100.0%)
RestoreSensor
-
-
-
-
RestoreAdvanced
SureScan MRI
-
-
-
-
Restore Sensor
SureScan MRI
-
-
-
-
RestoreUltra
SureScan MRI
-
-
-
-

 

Leads

From June 2004 to the report cut-off date of October 31, 2017, there were 8,765 leads followed in the registry. Differences between the total number of leads versus spinal cord neurostimulators (N=5,305) were due to the fact that some patients were subsequently re-implanted with a new lead or were implanted with more than 1 lead. The aggregate prospective follow-up time for all leads was 185,444 months (15,454 years).

A lead is a set of thin wires with a protective coating and electrodes near the tip (percutaneous lead) or on a paddle (surgical lead). The table below provides the number and percentage of leads by model.

Model

Number of Leads (%)

Vectris SureScan MRI Compact (977A2) a

2,602 (29.7%)

Pisces Octad Compact (3778) a

2,163 (24.7%)

Pisces Standard (3487A) a

980 (11.2%)

Pisces Octad Standard (3777) a

834 (9.5%)

Pisces Plus (3888) a

443 (5.1%)

Specify 5-6-5 (39565) b

282 (3.2%)

Pisces Compact (3887) a

196 (2.2%)

Pisces Octad Subcompact (3776) a

185 (2.1%)

Vectris SureScan MRI Subcompact (977A1) a

117 (1.3%)

Specify 2x8 (39286) b

32 (0.4%)

Specify SureScan MRI  5-6-5 (977C1) b

30 (0.3%)

Specify SureScan MRI 2x8 (977C2) b

10 (0.1%)

Other/Unspecified

215 (2.5%)

Leads No Longer Manufactured

Specify (3998) b

155 (1.8%)

Pisces Z Standard (3890) a

141 (1.6%)

Pisces Z Compact (3891) a

130 (1.5%)

Resume TL (3986A) b

108 (1.2%)

Hinged Specify (3999) b

54 (0.6%)

Resume II (3587A) b

52 (0.6%)

Pisces Z Plus (3892) a

25 (0.3%)

On-Point (3987A) b

9 (0.1%)

SymMix (3982A) b

2 (<0.1%)

Total

8,765 (100%)

a Percutaneous lead
b Surgical lead

Percutaneous leads composed over eighty-nine percent (89.2%%) of leads in the registry (7,816/8,765), including 36.3% (3,182/8,765) in the Pisces-Octad lead family, 31.0% (2,719/8,765) in the Vectris SureScan MRI lead family, 18.5% (1,619/8,765) in the Pisces-Quad lead family, and 3.4% (296/8,765) in the Pisces-Quad Z lead family. Over eight percent (8.4%) of leads (734/8,765) were surgical leads. A small percent (2.5%) of leads (215/8,765) were designated as “Other” or were unspecified in the database.

Lead EventsLead Events

There were 1,025 product performance-related events with an underlying reported etiology related to the lead. This includes 1,001 events with a lead etiology and 24 events with both a lead and other etiology (including device and non-device etiologies). Of these events, the majority were lead migration/dislodgements (n=562), high impedance (n=275), and lead fracture (n=69). Of the 1,025 lead events, 889 were the initial product performance event that affected lead survival estimates. There were 820 events in the 7816 (10.5%) percutaneous leads, 50 events in the 734 (6.8%) surgical leads, and 19 events occurred in a lead with an unknown/other model number.

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off.  For leads:

  • 889 had follow-up time cut-off due to product performance-related events. 
  • 5,091 were censored in the survival analysis for the following reasons: patient expired, neurostimulator explanted, patient discontinued, therapy suspended, or site discontinued participation in the registry.
  • 2,785 were free from product performance-related events and censoring events, were censored at the last follow-up prior to the report cut-off.

Lead SurvivalLead Survival

The tables below represent annual lead survival and 95% confidence intervals where at least 20 leads contributed to each 3-month interval.

                                                  

Model 3487A Pisces-Quad: Survival from Lead Events

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

Model 3487A: Survival from Lead Events

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Lead Characteristics
Model Number
3487A
FDA Approval Date
May 1988
Leads Enrolled
980
Leads Currently Active in Study
112
Device Events
199
Cumulative Months of Follow-up
32,353
Model 3487A Pisces-Quad: Event Summary Table
Lead Event
Total
High impedance
87
Lead migration/dislodgement
55
Low impedance
25
Device stimulation issue
17
Lead fracture
13
Inadequate lead connection
2
Total Lead Events
199
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
90.2%
(87.4%, 92.4%)
497
2 yrs
87.4%
(84.3%, 89.9%)
406
3 yrs
80.7%
(76.9%, 83.9%)
331
4 yrs
73.6%
(69.2%, 77.4%)
244
5 yrs
69.0%
(64.3%, 73.3%)
205
6 yrs
64.7%
(59.6%, 69.3%)
172
7 yrs
62.3%
(57.1%, 67.1%)
143
8 yrs
62.3%
(57.1%, 67.1%)
107
9 yrs
56.3%
(50.3%, 61.8%)
93
10 yrs
53.7%
(47.5%, 59.5%)
77
11 yrs
50.6%
(44.0%, 56.8%)
55
12 yrs
46.8%
(39.5%, 53.8%)
35
at 156 mo
46.8%
(39.5%, 53.8%)
22

Model 3487A Pisces-Quad: Specifications

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

Model 3887 Pisces-Quad: Survival from Lead Events

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

Model 3887 Pisces-Quad: Survival from Lead Events

View Larger Image

Lead Characteristics
Model Number
3887
FDA Approval Date
Jan 1997
Leads Enrolled
196
Leads Currently Active in Study
53
Device Events
29
Cumulative Months of Follow-up
5,202
Model 3887 Pisces-Quad: Event Summary Table
Lead Event
Total
Lead migration/dislodgement
14
Lead fracture
8
High impedance
4
Device stimulation issue
2
Device lead damage
1
Total Lead Events
29
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
92.3%
(77.7%, 97.5%)
51
2 yrs
82.9%
(69.3%, 90.9%)
52
3 yrs
76.5%
(62.7%, 85.7%)
49
4 yrs
75.1%
(61.3%, 84.5%)
43
5 yrs
71.3%
(57.3%, 83.4%)
36
6 yrs
69.0%
(54.6%, 79.6%)
29
7 yrs
66.6%
(51.9%, 77.7%)
22
at 93 mo
66.6%
(51.9%, 77.7%)
20

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

View Larger Image

Lead Characteristics
Model Number
3888
FDA Approval Date
Nov 1992
Leads Enrolled
443
Leads Currently Active in Study
78
Device Events
42
Cumulative Months of Follow-up
8,835
Model 3888 Pisces-Quad: Event Summary Table
Lead Event
Total
Lead migration/dislodgement
28
High impedance
11
Device stimulation issue
2
Lead fracture
1
Total Lead Events
42
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
91.1%
(86.3%, 94.3%)
149
2 yrs
89.7%
(84.5%, 93.2%)
97
3 yrs
85.6%
(78.8%, 90.3%)
80
4 yrs
80.3%
(72.2%, 86.2%)
64
5 yrs
77.7%
(68.9%, 84.3%)
51
6 yrs
73.9%
(63.8%, 81.6%)
36
7 yrs
73.9%
(63.8%, 81.6%)
31
8 yrs
73.9%
(63.8%, 81.6%)
29
9 yrs
73.9%
(63.8%, 81.6%)
23
10 yrs
73.9%
(63.8%, 81.6%)
22
11 yrs
73.9%
(63.8%, 81.6%)
20
at 135 mo
73.9%
(63.8%, 81.6%)
20

Model 3888 Pisces-Quad: Specifications

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

Model 3890 Pisces-Quad LZ: Survival from Lead Events

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

Model 3890 Pisces-Quad LZ: Survival from Lead Events

View Larger Image


Lead Characteristics
Model Number
3890
FDA Approval Date
Sep 2002
Leads Enrolled
141
Leads Currently Active in Study
16
Device Events
10
Cumulative Months of Follow-up
3,158
Model 3890 Pisces-Quad LZ: Event Summary Table
Lead Event
Total
Lead migration/dislodgement
4
Impedance decreased
2
Lead fracture
2
High impedance
2
Total Lead Events
10
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100.0%
(NA)
38
2 yrs
97.8%
(85.1%, 99.7%)
51
3 yrs
89.4%
(76.4%, 95.5%)
40
4 yrs
89.4%
(76.4%, 95.5%)
33
5 yrs
83.8%
(68.8%, 92.0%)
22
at 66 mo
83.8%
(68.8%, 92.0%)
20

Model 3890 Pisces-Quad LZ: Specifications

Device name
Pisces Z Quad
ppr-3890
Lead Type
Percutaneous
Lead
Length (cm) 10 - 100
Diameter (mm) 1.3
Electrode
Number 4
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 3.0
Array Length (mm) 30.0

Model 3891 Pisces-Quad LZ: Survival from Lead Events

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

Model 3891 Pisces-Quad LZ: Survival from Lead Events

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Lead Characteristics
Model Number
3891
FDA Approval Date
Sep 2002
Leads Enrolled
130
Leads Currently Active in Study
17
Device Events
32
Cumulative Months of Follow-up
2,414
Model 3891 Pisces-Quad LZ: Event Summary Table
Lead Event
Total
Lead migration/dislodgement
18
Lead fracture
6
Device stimulation issue
4
Device lead damage
2
High impedance
2
Total Lead Events
32
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
81.7%
(71.4%, 88.5%)
56
2 yrs
78.7%
(67.9%, 86.2%)
37
at 30 mo
63.9%
(49.3%, 75.3%)
21

Model 3891 Pisces-Quad LZ: Specifications

Device Name
Pisces Z
Quad Compact
ppr-3891
Lead Type
Percutaneous
Lead
Length (cm) 10 - 100
Diameter (mm) 1.3
Electrode
Number 4
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 3.0
Array Length (mm) 24.0

Model 3776 Pisces-Octad: Survival from Lead Events

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

Model 3776 Pisces-Octad: Survival from Lead Events

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Lead Characteristics
Model Number
3776
FDA Approval Date
Nov 2005
Leads Enrolled
185
Leads Currently Active in Study
36
Device Events
14
Cumulative Months of Follow-up
4,208
Model 3776 Pisces-Octad: Event Summary Table
Lead Event
Total
Lead migration/dislodgement
10
High impedance
2
Device stimulation issue
1
Lead fracture
1
Total Lead Events
14
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
91.6%
(85.4%, 95.3%)
84
2 yrs
91.6%
(85.4%, 95.3%)
61
3 yrs
91.6%
(85.4%, 95.3%)
43
4 yrs
89.4%
(81.1%, 94.2%)
29
5 yrs
89.4%
(81.1%, 94.2%)
20
at 63 mo
89.4%
(81.1%, 94.2%)
20

Model 3776 Pisces-Octad: Specifications

Device Name
1x8
Sub-compact
ppr-3776
Lead Type
Percutaneous
Lead
Length (cm) 45, 60, 75
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 1.5
Array Length (mm) 35.0

Model 3777 Pisces-Octad: Survival from Lead Events

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

Model 3777 Pisces-Octad: Survival from Lead Events

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Lead Characteristics
Model Number
3777
FDA Approval Date
Apr 2005
Leads Enrolled
834
Leads Currently Active in Study
120
Device Events
68
Cumulative Months of Follow-up
19,221
Model 3777 Pisces-Octad: Event Summary Table
Lead Event
Total
Lead migration/dislodgement
40
High impedance
15
Device stimulation issue
7
Device lead damage
2
Lead fracture
2
Low impedance
2
Total Lead Events
68
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
92.8%
(90.2%, 94.7%)
435
2 yrs

89.6%
(86.4%, 92.0%)

274
3 yrs
89.6%
(86.4%, 92.0%)
173
4 yrs
89.0%
(85.6%, 91.6%)
111
5 yrs
88.1%
(84.2%, 91.1%)
85
6 yrs
85.8%
(80.5%, 89.7%)
68
7 yrs
83.0%
(76.3%, 88.0%)
45
8 yrs
78.7%
(69.2%, 85.5%)
34
9 yrs
74.4%
(63.4%, 82.6%)
44
10 yrs
74.4%
(63.4%, 82.6%)
33
at 129 mo
69.6%
(57.1%, 79.1%)
21

 

Model 3777 Pisces-Octad: Specifications

Device Name
1x8
Standard
ppr-3777
Lead Type
Percutaneous
Lead
Length (cm) 45, 60, 75
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 6.0
Array Length (mm) 66.0

Model 3778 Pisces-Octad: Survival from Lead Events

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

Model 3778 Pisces-Octad: Survival from Lead Events

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Lead Characteristics
Model Number
3778
FDA Approval Date
Apr 2005
Leads Enrolled
2,163
Leads Currently Active in Study
333
Device Events
274
Cumulative Months of Follow-up
54,152
Model 3778 Pisces-Octad: Event Summary Table
Lead Event
Total
Lead migration/dislodgement
204
High impedance
36
Lead fracture
18
Device stimulation issue
6
Medical device complicationa
4
Device lead damage
2
Device malfunctionb
2
Impedance increased
1
Low impedance
1
Total Lead Events
274

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

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
89.8%
(88.2%, 91.2%)
1,209
2 yrs
86.1%
(84.2%, 87.8%)
799
3 yrs
84.2%
(82.0%, 86.0%)
582
4 yrs
83.6%
(81.4%, 85.6%)
406
5 yrs
80.4%
(77.6%, 82.9%)
263
6 yrs
78.4%
(75.1%, 81.3%)
177
7 yrs
74.9%
(70.7%, 78.6%)
113
8 yrs
70.7%
(65.2%, 75.5%)
74
9 yrs
70.7%
(65.2%, 75.5%)
36
at 114 mo
70.7%
(65.2%, 75.5%)
23

Model 3778 Pisces-Octad: Specifications

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

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

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

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

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Lead Characteristics
Model Number
977A1
FDA Approval Date
Mar 2013
Leads Enrolled
117
Leads Currently Active in Study
67
Device Events
6
Cumulative Months of Follow-up
1,804
Model 977A1 Vectris SureScan MRI 1x8 Subcompact:
Event Summary Table
Lead Event
Total
Lead migration/dislodgement
3
Device lead fracture
2
High impedance
1
Total Lead Events
6
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
97.7%
(91.1%, 99.4%)
65
2 yrs
89.1%
(75.9%, 95.3%)
27
at 27 mo
89.1%
(75.9%, 95.3%)
22

Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Specifications

Device Name
Vectris SureScan MRI
1x8 Subcompact
Model 977A1 Vectris SureScan MRI
Lead Type
Percutaneous
Lead
Length (cm) 60, 75, 90
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 1.5
Array Length (mm) 34.5

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

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

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

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Lead Characteristics
Model Number
977A2
FDA Approval Date
Mar 2013
Leads Enrolled
2,602
Leads Currently Active in Study
1,774
Device Events
145
Cumulative Months of Follow-up
33,287
Model 977A2 Vectris SureScan MRI 1x8 Compact:
Event Summary Table
Lead Event
Total
Lead migration/dislodgement
108
High impedance
28
Lead fracture
7
Impedance increased
1
Low impedance
1
Total Lead Events
145
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
94.3%
(93.1%, 95.3%)
1,161
2 yrs
90.7%
(88.8%, 92.2%)
501
3 yrs
88.8%
(86.1%, 91.0%)
144
at 45 mo
87.5%
(84.2%, 90.2%)
30

Model 977A2 Vectris SureScan MRI 1x8 Compact: Specifications

Device Name
Vectris SureScan MRI
1x8 Compact
Model 977A2 Vectris SureScan MRI
Lead Type
Percutaneous
Lead
Length (cm) 60, 75, 90
Diameter (mm) 1.3
Electrode
Number 8
Shape Cylindrical
Length (mm) 3.0
Individual Surface Area (mm) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 4.0
Array Length (mm) 52.0

Model 3986A Resume TL: Survival from Lead Events

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

Model 3986A Resume TL: Survival from Lead Events

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Lead Characteristics
Model Number
3986A
FDA Clearance Date
Apr 1995
Leads Enrolled
108
Leads Currently Active in Study
14
Device Events
19
Cumulative Months of Follow-up
3,528
Model 3986A Resume TL: Event Summary Table
Lead Event
Total
High impedance
10
Device connection issue
2
Device stimulation issue
2
Low impedance
2
Lead migration/dislodgement
2
Lead fracture
1
Total Lead Events
19
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
84.2%
(73.3%, 91.0%)
48
2 yrs
84.2%
(73.3%, 91.0%)
38
3 yrs
82.0%
(70.3%, 89.5%)
30
4 yrs
82.0%
(70.3%, 89.5%)
33
5 yrs
82.0%
(70.3%, 89.5%)
29
6 yrs
75.5%
(60.6%, 85.4%)
22
at 75 mo
75.5%
(60.6%, 85.4%)
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
155
Leads Currently Active in Study
24
Device Events
10
Cumulative Months of Follow-up
3,352
Model 3998 Specify: Event Summary Table
Lead Event
Total
High impedance
4
Lead fracture
3
Lead migration/dislodgement
2
Device stimulation issue
1
Total Lead Events
10
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
97.1%
(88.7%, 99.3%)
60
2 yrs
91.7%
(81.1%, 96.5%)
41
3 yrs
88.7%
(75.8%, 94.9%)
20

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
282
Leads Currently Active in Study
75
Device Events
13
Cumulative Months of Follow-up
5,507
Model 39565 Specify: Event Summary Table

Lead Event

Total

Lead migration/dislodgement

10

High impedance

1

Lead fracture

1

Lead insulation failure

1

Total Lead Events

13

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
96.3%
(92.7%, 98.1%)
153
2 yrs
95.6%
(91.6%, 97.7%)
94
3 yrs
95.6%
(91.6%, 97.7%)
43
4 yrs
89.6%
(77.2%, 95.4%)
23
at 51 mo
89.6%
(77.2%, 95.4%)
21

Model 39565 Specify: Specifications

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

Lead Survival SummaryLead Survival Summary

Lead Characteristics
Model Number
Family
FDA Approval Date
Leads Enrolled
Leads Currently Active in Study
Device Eventsa
Cumulative Months of Follow-up
Percutaneous Leads
3487A
Pisces-Quad
May 1988
980
112
199
32,353 
3887
Pisces-Quad
Jan 1997
196
53
29
5,202
3888
Pisces-Quad
Nov 1992
443
78
42
8,835
3890
Pisces-Quad LZ
Sep 2002
141
16
10
3,158
3891
Pisces-Quad LZ
Sep 2002
130
17
32
2,414
3776
Pisces-Octad
Nov 2005
185
36
14
4,208
3777
Pisces-Octad
Apr 2005
834
120
68
19,221
3778
Pisces-Octad
Apr 2005
2,163
333
274
54,152
977A1
Vectris SureScan
Mar 2013
117
67
6
1,804
977A2
Vectris SureScan
Mar 2013
2,602
1,774
145
33,287
Surgical Leads
3986A
Resume TL
Apr 1995b
108
14
19
3,528
3998
Specify
Feb 1998
155
24
10
3,352
39565
Specify
Jun 2007
282
75
13
5,507

a There were a total of 1025 lead-related events reported to the registry, but only 861 events included in this summary table. The remaining lead-related events occurred in lead models for which no device survival data are presented due to an insufficient number of enrolled devices (n=9), leads with an unknown model numbers (n=19), or were subsequent device events (i.e. additional events that occurred after the survival censoring event) that did not affect the survival estimates.
b FDA clearance date.

Device Survival Probability (95% Confidence Interval)Table 1 of 3
Model
Number
Family
1 yr
2 yrs
3 yrs
4 yrs
Percutaneous Leads
3487A
Pisces-Quad
90.2%
(87.4%,
92.4%)
87.4%
(84.3%,
89.9%)
80.7%
(76.9%,
83.9%)
73.6%
(69.2%,
77.4%)
3887
Pisces-Quad
92.3%
(77.7%, 97.5%)
82.9%
(69.3%, 90.9%)
76.5%
(62.7%, 85.7%)
75.1%
(61.3%, 84.5%)
3888
Pisces-Quad
91.1%
(86.3%, 94.3%)
89.7%
(84.5%, 93.2%)
85.6%
(78.8%, 90.3%)
80.3%
(72.2%, 86.2%)
3890
Pisces-Quad LZ
100.0%
(NA)
97.8%
(85.1%, 99.7%)
89.4%
(76.4%, 95.5%)
89.4%
(76.4%, 95.5%)
3891
Pisces-Quad LZ
81.7%
(71.4%, 88.5%)
78.7%
(67.9%, 86.2%)
-
-
3776
Pisces-Octad
91.6%
(85.4%, 95.3%)
91.6%
(85.4%, 95.3%)
91.6%
(85.4%, 95.3%)
89.4%
(91.1%, 94.2%)
3777
Pisces-Octad
92.8%
(90.2%, 94.7%)
89.6%
(86.4%, 92.0%)
89.6%
(86.4%, 92.0%)
89.0%
(85.6%, 91.6%)
3778
Pisces-Octad
89.9%
(88.2%, 91.2%)
86.1%
(84.2%, 87.8%)
84.2%
(82.0%, 86.0%)
83.6%
(81.4%, 85.6%)
977A1
Vectris SureScan
97.7%
(91.1%, 99.4%)
89.1%
(75.9%, 95.3%)
-
-
977A2
Vectris SureScan
94.3%
(93.1%, 95.3%)

90.7%
(88.8%, 92.2%)

88.8%
(86.1% 91.0%)
-
Surgical Leads
3986A
Resume TL
84.2%
(73.3%, 91.0%)
84.2%
(73.3%, 91.0%)
82.0%
(70.3%, 89.5%)
82.0%
(70.3%, 89.5%)
3998
Specify
97.1%
(88.7%, 99.3%)
91.7%
(81.1%, 96.5%)
88.7%
(75.8% 94.9%)
-
39565
Specify
96.3%
(92.7%, 98.1%)
95.6%
(91.6%, 97.7%)
95.6%
(91.6%, 97.7%)
89.6% (77.2%, 95.4%)

 

Device Survival Probability (95% Confidence Interval)Table 2 of 3
Model
Number
Family
5 yrs
6 yrs
7 yrs
8 yrs
Percutaneous Leads
3487A
Pisces-Quad
69.0%
(64.3%, 73.3%)
64.7%
(59.6%, 69.3%)
62.3%
(57.1%, 67.1%)
62.3%
(57.1%, 67.1%)
3887
Pisces-Quad
71.3%
(57.3%, 81.4%)
69.0%
(54.6%, 79.6%)
66.6%
(51.9%, 77.7%)
-
3888
Pisces-Quad
77.7%
(68.9%, 84.3%)
73.9%
(63.8%, 81.6%)
73.9%
(63.8%, 81.6%)
73.9%
(63.8%, 81.6%)
3890
Pisces-Quad LZ
83.8%
(68.8%, 92.0%)
-
-
-
3891
Pisces-Quad LZ
-
-
-
-
3776
Pisces-Octad
89.4%
(81.1%, 94.2%)
-
-
-
3777
Pisces-Octad
88.1%
(84.2%, 91.1%)
85.8%
(80.5%, 89.7%)
83.0%
(76.3%, 88.0%)
78.7%
(69.2%, 85.5%)
3778
Pisces-Octad
80.4%
(77.6%, 82.9%)
78.4%
(75.1%, 81.3%)
74.9%
(70.7%, 78.6%)
70.7%
(65.2%, 75.5%)
977A1
Vectris SureScan
-
-
-
-
977A2
Vectris SureScan
-
-
-
-
Surgical Leads
3986A
Resume TL
82.0%
(70.3%, 89.5%)
75.5%
(60.6%, 85.4%)
-
-
3998
Specify
-
-
-
-
39565
Specify
-
-
-
-

 

Device Survival Probability (95% Confidence Interval)Table 3 of 3
Model
Number
Family
9 yrs
10 yrs
11 yrs
12 yrs
13 yrs
Percutaneous Leads
3487A
Pisces-Quad
56.3%
(50.3%, 61.8%)
53.7%
(47.5%, 59.5%)
50.6%
(44.0%, 56.8%)
46.8%
(39.5%, 53.8%)
46.8%
(39.5%, 53.8%)
3887
Pisces-Quad
-
-
-
-
-
3888
Pisces-Quad
73.9%
(63.8%, 81.6%)
73.9%
(63.8%, 81.6%)
73.9%
(63.8%, 81.6%)
-
-
3890
Pisces-Quad LZ
-
-
-
-
-
3891
Pisces-Quad LZ
-
-
-
-
-
3776
Pisces-Octad
-
-
-
-
-
3777
Pisces-Octad
74.4%
(63.4%, 82.6%)
74.4%
(63.4%, 82.6%)
-
-
-
3778
Pisces-Octad
70.7%
(65.2%, 75.5%)
-
-
-
-
977A1
Vectris SureScan
-
-
-
-
-
977A2
Vectris SureScan
-
-
-
-
-
Surgical Leads
3986A
Resume TL
-
-
-
-
-
3998
Specify
-
-
-
-
-
39565
Specify
-
-
-
-
-

 

Extensions

From June 2004 to the report cut-off date of October 31, 2017, there were 3,364 extensions followed in the registry.  Differences between the total number of extensions versus spinal cord neurostimulators (N=5,305) were due to the fact that some systems did not use an extension. The aggregate prospective follow-up time for all extensions was 88,699 months (7,392 years).

An extension is a set of thin wires with a protective coating that connects the neurostimulator to the lead. The table below provides the number and percentage of extensions by model.

Extensions by Model
Model
Number of Extensions (%)
37081 (1x8)
1,427 (42.4%)
37082 (bifurcated stretch coil)
628 (18.7%)
37083 (single stretch coil)
228 (6.8%)
Other/Unspecified
17 (0.5%)
Extensions No Longer Manufactured
7489 (Low profile quadripolar)
752 (22.4%)
7495 (quadripolar in-line)
270 (8.0%)
7472 (bifurcated 1x8)
24 (0.7%)
7496 (quadripolar)
9 (0.3%)
7471 (1x8)
9 (0.3%)
Total
3,364 (100%)

Extension EventsExtension Events

There were 45 product performance-related events with an underlying reported etiology related to the extension. This includes 35 events with an extension etiology and 10 events with both an extension and other etiology (including device and non-device etiologies).  Of these events, the majority were extension fractures (n=17). Of the 45 events, 36 were the initial product performance event that affected extension survival estimates.

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off.  For extensions:

  • 36 had follow-up time cut-off due to product performance-related events.
  • 2,659 were censored in the survival analysis for the following reasons: patient expired, extension explanted, site termination, patient discontinued, or therapy suspended.
  • 669 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.

Extension Survival Extension Survival

The figures and tables below represent extension survival and 95% confidence intervals where at least 20 extensions contributed to each 3-month interval. 

                                
   

Model 37081: Survival from Extension Events

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

Model 37081: Survival from Extension Events

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Extension Characteristics
Model Number
37081
FDA Approval Date
Apr 2005
Extensions Enrolled
1,427
Extensions Currently Active in Study
401
Device Events
14
Cumulative Months of Follow-up
33,949
Model 37081 Extension: Event Summary Table
Extension Event
Total
Extension fracture
6
High impedance
6
Extension migration
1
Low impedance
1
Total Extension Events
14
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.8%
(99.2%, 99.9%)
780
2 yrs
98.9%
(97.8%, 99.5%)
484
3 yrs
98.4%
(97.0%, 99.2%)
301
4 yrs
98.4%
(97.0%, 99.2%)
226
5 yrs
98.4%
(97.0%, 99.2%)
154
6 yrs
98.4%
(97.0%, 99.2%)
124
7 yrs
98.4%
(97.0%, 99.2%)
85
8 yrs
98.4%
(97.0%, 99.2%)
71
9 yrs
95.1%
(87.7%, 98.1%)
44
10 yrs
95.1%
(87.7%, 98.1%)
26

Model 37081: Specifications

Device Name
1x8 Extension
Model 37081: 1x8 Extension
Length (cm) 20, 40, 60
Distal End Compatibility 1 Octad Lead
Distal End Set Screws 1
Proximal End INS Compatibility Restore Family

Model 37082: Survival from Extension Events

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

Model 37082: Survival from Extension Events

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Extension Characteristics
Model Number
37082
FDA Approval Date
Mar 2006
Extensions Enrolled
628
Extensions Currently Active in Study
67
Device Events
5
Cumulative Months of Follow-up
20,484
Model 37082 Extension: Event Summary Table
Extension Event
Total
Device connection issue
2
Extension fracture
2
Paraesthesiaa
1
Total Extension Events
5

a Reported as shocking sensation at battery/extension connection.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.6%
(98.4%, 99.9%)
415
2 yrs
99.3%
(98.0%, 99.8%)
293
3 yrs
99.3%
(98.0%, 99.8%)
202
4 yrs
99.3%
(98.0%, 99.8%)
143
5 yrs
99.3%
(98.0%, 99.8%)
120
6 yrs
99.3%
(98.0%, 99.8%)
99
7 yrs
97.1%
(91.6%, 99.0%)
77
8 yrs
97.1%
(91.6%, 99.0%)
50
9 yrs
97.1%
(91.6%, 99.0%)
35
at 117 mo
97.1%
(91.6%, 99.0%)
22

Model 37082: Specifications

Device Name
Bifurcated Stretch-Coil Extension
Model 37082: Bifurcated Stretch-Coil Extension
Length (cm) 20, 40, 60
Distal End Compatibility 2 Quad Leads
Distal End Set Screws 8 (4 per Lead)
Proximal End INS Compatibility Restore Family

Model 37083: Survival from Extension Events

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

Model 37083: Survival from Extension Events

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Extension Characteristics
Model Number
37083
FDA Approval Date
Sep 2005
Extensions Enrolled
228
Extensions Currently Active in Study
44
Device Events
7
Cumulative Months of Follow-up
6,531
Model 37083 Extension: Event Summary Table
Extension Event
Total
Extension fracture
5
Device failurea
1
Extension migration
1
Total Extension Events
7

a Reported as extension failure

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.2%
(94.3%, 99.9%)
131
2 yrs
97.5%
(92.6%, 99.2%)
108
3 yrs
96.5%
(90.9%, 98.7%)
63
4 yrs
96.5%
(90.9%, 98.7%)
46
5 yrs
96.5%
(90.9%, 98.7%)
34
6 yrs
91.0%
(78.5%, 96.4%)
29
7 yrs
91.0%
(78.5%, 96.4%)
28
8 yrs
91.0%
(78.5%, 96.4%)
24
at 102 mo
91.0%
(78.5%, 96.4%)
21

 

Model 37083: Specifications

Device Name
Single Stretch-Coil Extension
Model 37083: Single Stretch-Coil Extension
Length (cm) 20, 40, 60
Distal End Compatibility 1 Quad Lead
Distal End Set Screws 4
Proximal End INS Compatibility Restore Family

Model 7489: Survival from Extension Events

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

Model 7489: Survival from Extension Events

View Larger Image

Extension Characteristics
Model Number
7489
FDA Approval Date
Oct 2002
Extensions Enrolled
752
Extensions Currently Active in Study
87
Device Events
5
Cumulative Months of Follow-up
18,823
Model 7489 Extension: Event Summary Table
Extension Event
Total
Extension fracture
2
Extension migration
2
Medical device complicationa
1
Total Extension Events
5

a Reported as unknown problem with extension

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.1% 
(96.5%, 99.8%)
294
2 yrs
99.1% 
(96.5%, 99.8%)
290
3 yrs
98.3% 
(95.6%, 99.4%)
205
4 yrs
98.3% 
(95.6%, 99.4%)
138
5 yrs
98.3% 
(95.6%, 99.4%)
103
6 yrs
98.3% 
(95.6%, 99.4%)
83
7 yrs
98.3% 
(95.6%, 99.4%)
64
8 yrs
98.3% 
(95.6%, 99.4%)
62
9 yrs
98.3% 
(95.6%, 99.4%)
61
10 yrs
98.3% 
(95.6%, 99.4%)
62
11 yrs
98.3% 
(95.6%, 99.4%)
64
12 yrs
98.3% 
(95.6%, 99.4%)
49
at 153 mo
98.3% 
(95.6%, 99.4%)
20

Model 7489: Specifications

Device Name
Low Profile Quad Extension
Model 7489: Low Profile Quad Extension
Length (cm) 10, 25, 40, 51, 66
Distal End Compatibility 1 Quad Lead
Distal End Set Screws 4
Proximal End INS Compatibility Itrel 3, Synergy, Versitrel

Extension Survival SummaryExtension Survival Summary

 

Extension Characteristics
Model Number
Family
FDA Approval Date
Extensions Enrolled
Extensions Currently Active in Study
Device Eventsa
Cumulative Months of Follow-up
37081
37081
Apr
2005
1,427
401
14
33,949
37082
37082
Mar
2006
628
67
5
20,484
37083
37083
Sep
2005
228
44
7
6,531
7489
7489
Oct
2002
752
87
5
18,823

a There were a total of 45 extension-related events reported to the registry, but only 31 events are included in this summary table. The remaining extension-related events occurred in an extension model for which no device survival data is presented due to an insufficient number of enrolled devices (n=5 ), or were subsequent device events (i.e. additional events that occurred after the survival censoring event) that did not affect the survival estimates.

Device Survival Probability (95% Confidence Interval)Table 1 of 2
Model Number
1 yr
2 yrs
3 yrs
4 yrs
5 yrs
6 yrs
37081
99.8%
(99.2%, 99.9%)
98.9%
(97.8%, 99.5%)
98.4%
(97.0%, 99.2%)
98.4%
(97.0%, 99.2%)
98.4%
(97.0%, 99.2%)
98.4%
(97.0%, 99.2%)
37082
99.6%
(98.4%, 99.9%)
99.3%
(98.0%, 99.8%)
99.3%
(98.0%, 99.8%)
99.3%
(98.0%, 99.8%)
99.3%
(98.0%, 99.8%)
99.3%
(98.0%, 99.8%)
37083
99.2%
(94.3%, 99.9%)
97.5%
(92.6%, 99.2%)
96.5%
(90.9%, 98.7%)
96.5%
(90.9%, 98.7%)
96.5%
(90.9%, 98.7%)
91.0%
(78.5%, 96.4%)
7489
99.1%
(96.5%, 99.8%)
99.1%
(96.5%, 99.8%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)

Device Survival Probability (95% Confidence Interval)Table 2 of 2
Model Number
7 yrs
8 yrs
9 yrs
10 yrs
11 yrs
12 yrs
37081
98.4%
(97.0%, 99.2%)
98.4%
(97.0%, 99.2%)
95.1%
(87.7%, 98.1%)
95.1%
(87.7%, 98.1%)
-
-
37082
97.1%
(91.6%, 99.0%)
97.1%
(91.6%, 99.0%)
97.1%
(91.6%, 99.0%)
-
-
-
37083
91.0%
(78.5%, 96.4%)
91.0%
(78.5%, 96.4%)
-
-
-
-
7489
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)
98.3%
(95.6%, 99.4%)

UC201906255EN

2017 Medtronic Product Performance Report: Data through October 31, 2017.

United States