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Sacral Neuromodulation Systems

Sacral Neuromodulation Systems

Study Participants

Centers

The following sacral neuromodulation tables and graphs were generated based on data collected between April 2010 and the report cut-off date of October 31, 2017. Twenty centers in North and South America enrolled and contributed patients to the sacral neuromodulation section of the report.


Patients

Of the 969 sacral neuromodulation patients enrolled, the primary indications for implant were as follows: 41.5% were implanted for the treatment of urinary urge incontinence, 31.8% were implanted for the treatment of urgency-frequency, 12.1% were implanted for the treatment of urinary retention, 4.7% were implanted for the treatment of fecal incontinence, 2.0% were implanted for the treatment of interstitial cystitis, 0.8% were implanted for the treatment of chronic pelvic pain syndrome, 0.7% were implanted for the treatment of bladder pain syndrome, 4.6% were implanted for the treatment of some other indication, and 1.8% were implanted for indications that were not specified in the database at the time of data cut-off.

Primary SNM Treatment IndicationsPrimary SNM Treatment Indications

Sacral Neuromodulation Primary Treatment Indications


Primary SNM Treatment Indications Chart
 

Primary Treatment Indicationa

Total Enrolled Patients
(Percent)

Urinary Urge Incontinence

402 (41.5%)

Urgency-Frequency

308 (31.8%)

Urinary Retention

117 (12.1%)

Fecal Incontinence

46 (4.7%)

Interstitial Cystitis

19 (2.0%)

Chronic Pelvic Pain Syndrome

8 (0.8%)

Bladder Pain Syndrome

7 (0.7%)

Other

45 (4.6%)

Not Specified

17 (1.8%)

Total Patients

969

a Refer to product labeling for approved indications.

 

Event Summary

There were 90 product-performance events reported between April 2010 and October 31, 2017, in patients with sacral neuromodulation systems. These events represent 17.0% of the total reported events (90/530). These events occurred in 76 of the 969 total patients (7.8%) enrolled and are presented graphically within this report (e.g. events per patient years as well as survival curves).

In addition, there were 440 non-product performance events that were collected to understand patient experience (clinical signs and symptoms) with the sacral neuromodulation systems. There were also 18 deaths reported for patients followed in the PSR with sacral neuromodulation systems, none of which were reported as a direct result of a product performance event.

Sacral Neuromodulation System Product Performance Events

Event a

Number of
Product Performance
Events

Events per
100 Patient Years

Number of
Patients with Event

Percent of
Patients with Event

(N=969)

High impedance

38

2.59

32

3.3%

Lead migration/dislodgement

18

1.23

16

1.7%

Lead fracture

15

1.02

14

1.4%

Low impedance

7

0.48

7

0.7%

Device battery issue

4

0.27

3

0.3%

Device malfunction b

4

0.27

4

0.4%

Device electrical impedance issue

2

0.14

1

0.1%

Device lead issue

1

0.07

1

0.1%

Device telemetry issue

1

0.07

1

0.1%

Totals

90

6.13

76

7.8%

a Medical Dictionary for Regulatory Activities (MedDRA) Lower-Level Term or Medtronic’s coding system term for events that do not exist in the MedDRA dictionary.
b See Neurostimulator Event Summary Tables for additional details on device malfunctions by model.

A total of 72 (80.0%) of the 90 product performance events were related to the lead, 10 (11.1%) were related to the neurostimulator, 2 (2.2%) were related to the extension, 2 (2.2%) were related to programming/stimulation, 3 (3.3%) were related to “multiple etiologies”, which includes events where at least one device and one non-device etiology was indicated, and 1(1.1%) was related to some “other etiology”. Relatedness is determined by the physician.

Product Performance Events by Relatednessa

Product Performance Events by Relatedness  

aEach 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.

Sacral Neuromodulation 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

Infections - pathogen unspecified

225

   Urinary tract infection c

201

   Medical device site infection

16

   Wound infection

6

   Other d

2

Therapeutic and nontherapeutic effects (excluding toxicity)

68

   Therapeutic product ineffective

53

   Therapeutic response decreased

15

Complications associated with device

46

   Medical device site pain

36

   Medical device discomfort

5

   Other d

5

Device issues

19

   Device stimulation issue

9

   Neurostimulator migration

5

   Other d

5

Neurological disorders Not Elsewhere Classified (NEC)

18

   Paraesthesia

14

   Other d

4

Urinary tract signs and symptoms

17

   Urinary incontinence

5

   Other d

12

Musculoskeletal and connective tissue disorders NEC

8

   Pain in extremity

5

   Other d

3

Injuries NEC

5

   Wound secretion

5

Other d

34

Total

440

a Adverse events associated with product performance events are not included in this table.
b Medical Dictionary for Regulatory Activities (MedDRA) or Medtronic's own coding system terms for events that do not exist in the MedDRA dictionary.
c Therapy relevant event collected per registry protocol but not device related.
d Comprised of event terms with fewer than five events each.

There were 18 deaths reported for patients in the registry, none of which were reported as being related to a product performance event. Ten deaths occurred in patients with a primary indication of urgency-frequency, three deaths in patients with a primary indication of urinary urge incontinence, two in patients with a primary indication of urinary retention and three deaths in patients for other indications.

Number of Reports of Death by Primary Indication
Primary Indicationa
N (%) of deaths
Urgency-frequency
10 (55.6%)
Urinary urge incontinence
3 (16.7%)
Urinary retention
2 (11.1%)
Otherb
3 (16.7%)
Total
18 (100%)

a Refer to product labeling for approved indications.
b Includes 1 indication of atony of bladder, 1 of neurogenic bladder, and 1 of BPH without urinary obstruction.

Neurostimulators

From April 2010 to the report cut-off date of October 31, 2017, 910 neurostimulators were followed in the registry. The difference between the total number of patients (n=969) versus neurostimulators (n=910) is due to the fact that patients could enroll prior to implant but may not have received an implanted device, or patients were enrolled but not implanted, before the data cut-off.

Over eighty-eight percent (88.9%) of neurostimulators were InterStim II (n=809), and 11.1% (n=101) were InterStim I. The aggregate prospective follow-up time for all neurostimulators was 17,068 months (1422 years).

Neurostimulator Events Neurostimulator Events

There were 11 product performance-related events with an underlying reported etiology related to neurostimulator function. This includes 10 events with a neurostimulator etiology, and 1 event with both a neurostimulator and programming/stimulation etiology. All 11 of these events were the initial product performance event that affected neurostimulator survival estimates. For neurostimulators in the registry, the current return rate to Medtronic Returned Product Analysis (RPA) was 20/123 (16%). The proportion was based upon the number of registry neurostimulators received by RPA, divided by the total number of explanted devices plus the total number of stimulation devices in patients who have expired. There were no anomalies found in the 20 devices that were returned for analysis. The 11 neurostimulators with performance-related events were not returned to Medtronic RPA but were assigned as device-related by the physician as device malfunction (n=4), high impedance (n=3), device battery issue (n=3), and device electrical impedance 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 neurostimulators:

  • 11 had follow-up cut-off due to product performance-related events.
  • 373 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.
  • 526 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 figure and tables below represent neurostimulator survival and 95% confidence intervals where at least 20 neurostimulators contributed to each 3-month interval.

           

Model 3023 InterStim: Survival from Neurostimulator Events

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

Model 3023 InterStim: Survival from Neurostimulator Events

View Larger Image

Neurostimulator Characteristics
Model Name
InterStim
FDA Approval Date
Jul 1998
Neurostimulators Enrolled
101
Neurostimulators Currently Active in Study
31
Device Events
2
Cumulative Months of Follow-up
2,816

Model 3023 InterStim: Event Summary Table
Neurostimulator Event
Total
Device battery issue
1
Device malfunction a
1
Total Neurostimulator Events
2

a Device intermittently turning off.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr

98.9%
(92.2, 99.8%)

67
2 yrs

98.9%
(92.2, 99.8%)

50
3 yrs

98.9%
(92.2, 99.8%)

34
4 yrs

96.0%
(83.0, 99.1%)

21

Model 3023 InterStim: Specifications

Height 2.2 in (55 mm) Model 3023 InterStim
Width 2.4 in (60 mm)
Thickness 0.4 in (10 mm)
Volume 25 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
Programs 4
Implant Depth ≤ 4 cm

Model 3058 InterStim II: Survival from Neurostimulator Events

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

Model 3058 InterStim II: Survival from Neurostimulator Events

View Larger Image

Neurostimulator Characteristics
Model Name
InterStim II
FDA Approval Date
Jun 2006
Neurostimulators Enrolled
809
Neurostimulators Currently Active in Study
495
Device Events
9
Cumulative Months of Follow-up
14,252
Model 3058 InterStim II: Event Summary Table
Neurostimulator Event
Total
High impedancea
3
Device malfunctionb
3
Device battery issue
2
Device electrical impedance issuec
1
Total Neurostimulator Events
9

a Includes 3 events reported as high impedance attributed to both lead and neurostimulator.
b Includes 1 event reported as device function could not be restored after a fall, 1 event for battery heating up and 1 neurostimulator malfunction.
c Event reported as impedance out of range, physician did not specify whether high or low.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
99.6% 
(98.5%, 99.9%)
456
2 yrs
98.5% 
(96.6%, 99.3%)
252
3 yrs
97.4% 
(94.5%, 98.8%)
124
4 yrs
97.4% 
(94.5%, 98.8%)
34
at 51 mo
97.4% 
(94.5%, 98.8%)
21

Model 3058 InterStim II: Specifications

Height 1.7 in (44 mm) Model 3058 InterStim II
Width 2.0 in (51 mm)
Thickness 0.3 in (7.7 mm)
Volume 14 cc
Battery type Non-Rechargeable
Expected Battery life Depends on settings and use (additional Information)
Maximum Electrodes 4
Amplitude 0 - 8.5 V
Rate 2.1 - 130 Hz
Pulse Width 60 - 450 μsec
Programs 4
Implant Depth ≤ 2.5 cm

Neurostimulator Survival Summary Neurostimulator Survival Summary

Neurostimulator Characteristics
Model Name
Family
FDA
Approval
Date
Neuro-
stimulators
Enrolled
Neuro-
stimulators
Currently
Active in
Study
Device
Events
Cumulative
Months of
Follow-up
InterStim
InterStim
Jul
1998
101
31
2
2,816
InterStim II
InterStim
Jun
2006
809
495
9
14,252
Device Survival Probability (95% Confidence Interval)
Model Name
1 yr
2 yrs
3 yrs
4 yrs
InterStim

98.9%
(92.2, 99.8%)

98.9%
(92.2, 99.8%)

98.9%
(92.2, 99.8%)

96.0%
(83.0, 99.1%)

InterStim II
99.6%
(98.5%, 99.9%)

98.5%
(96.6%, 99.3%)

97.4%
(94.5%, 98.8%)
97.4%
(94.5%, 98.8%)

 

Leads

From April 2010 to the report cut-off date of October 31, 2017, there were 895 leads followed in the registry.  Differences between the total number of leads versus the total number of neurostimulators (N=910) were due to the fact that some patients were subsequently re-implanted with a new neurostimulator. The aggregate prospective follow-up time for all leads was 16,392 months (1,366 years).

The table below provides the number and percentage of leads by model.

Leads by Model
Model
Number of Leads (%)
3889 (tined)
795 (88.8%)
Other/Unknown
3 (0.3%)
Leads No Longer Manufactured
3093 (tined)
91 (10.2%)
3080
4 (0.5%)
3092
2 (0.2%)
Total
895 (100%)

Lead EventsLead Events

There were 74 product performance-related events with an underlying reported etiology related to the lead. This includes 72 events with a lead etiology and 2 events with both a lead and other etiology (including device and non-device etiologies). The majority of the events were high impedance (n=35). Of the 74 product performance-related lead events, 66 (89.1%) were the initial product performance event that affected lead 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 leads:

  • 66 had follow-up time cut-off due to product performance-related events.
  • 322 were censored in the survival analysis for the following reasons: patient expired, lead explanted, patient discontinued, therapy suspended, or site discontinued participating in the registry.
  • 507 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. 

               
   

Model 3889: Survival from Lead Events

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

Model 3889: Survival from Lead Events

View Larger Image

Lead Characteristics
Model Number
3889
FDA Approval Date
Sep 2002
Leads Enrolled
795
Leads Currently Active in Study
474
Device Events
60
Cumulative Months of Follow-up
14,163

a Lead coiled
b Battery depletion attributable to both neurostimulator and leads

Model 3889: Event Summary Table

Lead Event

Total

High impedance

28

Lead fracture

12

Lead migration/dislodgement

11

Low impedance

6

Device lead issue a

1

Device electrical impedance issue

1

Device battery issue b

1

Total Lead Events

60

a Lead coiled
b Battery depletion attributable to both neurostimulator and leads

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
95.3%
(93.1%, 96.8%)
410
2 yrs
90.4%
(87.2%, 92.8%)
226
3 yrs
85.2%
(80.3%, 89.0%)
113
4 yrs
83.1%
(77.4%, 87.6%)
53
5 yrs

81.2%
(74.0%, 86.6%)

33
6 yrs

78.7%
(69.7%, 85.3%)

24
at 75 mo
78.7%
(69.7%, 85.3%)
21

Model 3889 Tined Lead: Specifications

Model Number 3889 ppr-3889
Lead
Length (cm) 28, 33, 41
Diameter (mm) 1.27
Electrode
Number 4
Shape Cylindrical/coiled
Length (mm) 3.0
Individual Surface Area (mm2) 12.0
Inter-Electrode Spacing: Edge to Edge (mm) 3.0
Array Length (mm) 21.0

Model 3093: Survival from Lead Events

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

Model 3093: Survival from Lead Events

View Larger Image

Lead Characteristics
Model Number
3093
FDA Approval Date
Sep 2002
Leads Enrolled
91
Leads Currently Active in Study
45
Device Events
4
Cumulative Months of Follow-up
2,125
Model 3093: Event Summary Table
Lead Event
Total
Device lead damage
1
High impedance
1
Lead fracture
1
Lead migration/dislodgement
1
Total Lead Events
4
Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
98.3%
(88.5%, 99.8%)
49
2 yrs
94.0%
(82.4%, 98.0%)
34
3 yrs
94.0%
(82.4%, 98.0%)
21
at 39 mo
94.0%
(82.4%, 98.0%)
21

Model 3093 Tined Lead: Specifications

Model Number 3093 Model 3093 Tined Lead
Lead
Length (cm) 28, 33, 41
Diameter (mm) 1.27
Electrode
Number 4
Shape Cylindrical/coiled
Length (mm) 3.0 (3x) and 10.2 (1x)
Individual Surface Area (mm2) 12.0 and 40.7
Inter-Electrode Spacing: Edge to Edge (mm) 1.5
Array Length (mm) 23.7

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
3889
3889
Sep 2002
795
474
60
14,163
3093
3093
Sep 2002
91
45
4
2,125

a There were 74 lead-related events reported to the registry, but only 64 events included in this summary table. The remaining events occurred in a lead model for which no device survival curve is presented due to an insufficient number of enrolled devices (i.e., Model 3080) (n=2) or were subsequent events (i.e. additional events that occurred after the survival censoring event) that did not affect the device survival estimates.

Device Survival Probability (95% Confidence Interval)
Model
Number
1 yr
2 yrs
3 yrs
4 yrs
5 yrs
6 yrs
3889
95.3%
(93.1%, 96.8%)
90.4%
(87.2%, 92.8%)
85.2%
(80.3%, 89.0%)
83.1%
(77.4%, 87.6%)
81.2%
(74.0%, 86.6%)

78.7%
(69.7%, 85.3%)

3093
98.3%
(88.5%, 99.8%)
94.0%
(82.4%, 98.0%)
94.0%
(82.4%, 98.0%)
-
-
-

Extensions

From April 2010 to the report cut-off date of October 31, 2017, there were 101 extensions followed in the registry.  Differences between the total number of extensions versus the total neurostimulators (N=910) were due to the fact that not all systems require an extension, or some patients were subsequently re-implanted with a new neurostimulator.

All the extensions were Model 3095. The aggregate prospective follow-up time for all extensions was 2,849 months (237 years).

Extension EventsExtension Events

There were 2 product performance-related events with an underlying reported etiology related to the extension. Of these 2 events, 1 was 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:

  • 1 had follow-up time cut-off due to product performance-related events.
  • 65 were censored in the survival analysis for the following reasons: patient expired, extension explanted, or patient discontinued.
  • 35 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 figure and table below represent extension survival and 95% confidence intervals where at least 20 extensions contributed to each 3-month interval unless otherwise noted. 

                      
   

Model 3095: Survival from Extension Events

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

Model 3095: Survival from Extension Events

View Larger Image

Extension Characteristics
Model Number
3095
FDA Approval Date
Jul 1998
Extensions Enrolled
101
Extensions Currently Active in Study
35
Device Events
1
Cumulative Months of Follow-up
2,849
Model 3095: Event Summary Table
Lead fracturea
1
Total Extension Events
1

a Lead fracture attributed to both the lead and extension.

Time Interval
Survival
(95% Confidence Interval)
Sample Size
1 yr
100.0%
(NA)
62
2 yrs
98.3%
(88.3%, 99.8%)
45
3 yrs
98.3%
(88.3%, 99.8%)
28
at 45 mo
98.3%
(88.3%, 99.8%)
20

Model 3095 Extension: Specifications

Device Name Quadripolar Extension Model 3095 Quadripolar Extension
Length (cm) 10, 25, 51
Distal End Compatibility Tined lead models 3889 and 3093
Distal End Set Screws 4
Proximal End INS Compatibility InterStim Model 3023

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
3095
3095
Jul 1998
101
35
1
2,849
Device Survival Probability (95% Confidence Interval)
Model Number
1 yr
2 yrs
3 yrs
3095
100.0%
NA
98.3%
(88.3%, 99.8%)
98.3%
(88.3%, 99.8%)

a There were a total of 2 extension-related events reported to the registry, but only 1 event included in this summary table. The remaining event was a subsequent event (i.e. additional event that occurred after the survival censoring event) that did not affect the device survival estimates.

 

UC201906337 EN

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

United States