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Sacral Neuromodulation Systems

Sacral Neuromodulation Systems
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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 July 31, 2016. Nineteen centers enrolled and contributed patients to the sacral neuromodulation section of the report.


Patients

Of the 756 sacral neuromodulation patients enrolled, the primary indications for implant were as follows: 39.9% were implanted for the treatment of urinary urge incontinence, 33.2% were implanted for the treatment of urgency-frequency, 9.7% were implanted for the treatment of urinary retention, 5.8% were implanted for the treatment of some other indication, 5.3% were implanted for the treatment of fecal incontinence, 2.5% were implanted for the treatment of interstitial cystitis, 1.1% were implanted for the treatment of chronic pelvic pain syndrome, 0.3% were implanted for the treatment of bladder pain syndrome, and 2.2% were implanted for indications that were not specified in the database.

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 302 (39.9%)
Urgency-Frequency 251 (33.2%)
Urinary Retention 73 (9.7%)
Fecal Incontinence 40 (5.3%)
Interstitial Cystitis 19 (2.5%)
Chronic Pelvic Pain Syndrome 8 (1.1%)
Painful Bladder Syndrome 2 (0.3%)
Other 44 (5.8%)
Not specified 17 (2.2%)
Total Patients 756

a Refer to product labeling for approved indications.

 

Event Summary

There were 300 events reported between April 2010 and July 31, 2016 in patients with sacral neuromodulation systems. Of these events, 23.0% (69/300) were categorized as product performance-related and are presented graphically within this report. The 69 product performance events occurred in 57 of the 756 total patients (7.5%) enrolled. In addition, there were 231 non-product performance events reported. There were also 16 deaths reported for patients with sacral neuromodulation systems, none of which were reported as a direct result of a product performance event.

Sacral Neuromodulation System Product Performance Events
Eventa Number of Product
Performance
Events
Number of Patients with Event Percent of Patients with Event
(n=756)
High impedance 30 25 3.3%
Lead migration/dislodgement 12 11 1.5%
Lead fracture 9 8 1.0%
Low impedance 6 6 0.8%
Device battery issue 4 1 0.1%
Device electrical impedance issue 2 1 0.1%
Device malfunctionb 2 2 0.3%
Device lead damage 1 1 0.1%
Device lead issue 1 1 0.1%
Device telemetry issue 1 1 0.1%
Lead migration 1 1 0.1%
Total 69 57 7.5%

a Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term or Medtronic's coding system term for events that do not exist in the MedDRA dictionary.
b Includes 1 event reported as device function could not be restored after a fall and 1 neurostimulator malfunction.

A total of 55 (79.7%) of the 69 product performance events were related to the lead, 6 (8.7%) were related to the neurostimulator, 3 (4.3%) were related to the extension, 2 (2.9%) were related to "multiple etiologies", which includes events where at least one device and one non-device etiology was indicated, 1 (1.4%) was related to some "other device", 1 (1.4%) was related to some "other etiology", and 1 (1.4%) was related to programming/stimulation. Relatedness is determined by the physician.

Product Performance Events by Relatednessa

Product Performance Events by Relatedness  

aEach event could have more than one etiology.

Sacral Neuromodulation System Non-Product Performance Events (including adverse eventsa and device events, excluding deaths and normal battery depletions)
Eventsb Number of Non-Product Performance Events
Infections - pathogen unspecified 101
   Urinary tract infectionc 83
   Implant site infection 9
   Wound infection 4
   Incision site infection 2
   Cystitis 1
   Infection 1
   Postoperative wound infection 1
Therapeutic and nontherapeutic effects (excluding toxicity) 29
   Therapeutic product ineffective 27
   Therapeutic response decreased 2
Administration site reactions 26
   Implant site pain 25
   Implant site erythema 1
Device issues 20
   Device stimulation issue 14
   Neurostimulator migration 3
   Neurostimulator inversion 2
   Device extrusion 1
Urinary tract signs and symptoms 13
   Urinary incontinence 5
   Micturition urgency 3
   Urge incontinence 2
   Bladder pain 1
   Incontinence 1
   Urinary retention 1
Neurological disorders Not Elsewhere Classified (NEC) 11
   Paraesthesia 9
   Restless legs syndrome 1
   Sensory disturbance 1
General system disorders NEC 9
   Pain 5
   No anomaly found by RPAd 1
   Oedema 1
   Sensation of pressure 1
   Swelling 1
Bacterial infectious disorders 4
   Staphylococcal infection 2
   Cellulitis 1
   Implant site cellulitis 1
Therapeutic procedures and supportive care NEC 4
   Incisional drainage 3
   Wound drainage 1
Complications associated with device 2
   Medical device discomfort 2
Epidermal and dermal conditions 2
   Rash 1
   Skin reaction 1
Musculoskeletal and connective tissue disorders NEC 2
   Groin pain 1
   Pain in extremity 1
Reproductive tract disorders NEC 2
   Pelvic pain 2
Anal and rectal conditions NEC 1
   Proctalgia 1
Bone disorders (excluding congenital and fractures) 1
   Bone pain 1
Genitourinary tract disorders NEC 1
   Urinary tract disorder 1
Joint disorders 1
   Arthralgia 1
Procedural related injuries and complications NEC 1
   Procedural complication 1
Vulvovaginal disorders (excluding infections and inflammations) 1
   Vulvovaginal pain 1
Totals 231

a Adverse events associated with product performance events are not included in this table.
b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms 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 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 16 deaths reported for patients with sacral neuromodulation systems, none of which were reported as a direct result of a product performance event. Eight deaths occurred in patients receiving therapy for urgency-frequency, 4 deaths for other indications, 3 deaths for urinary urge incontinence and 1 for urinary retention.

Death by Primary Indication
Primary Indicationa N (%)
Urgency-frequency 8 (50.0%)
Otherb 4 (25.0%)
Urinary urge incontinence 3 (18.8%)
Urinary retention 1 (6.3%)
Total 16 (100%)

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

Neurostimulators

From April 2010 to the report cut-off date of July 31, 2016, 705 neurostimulators were followed in the registry. The difference between the total number of patients (n=756) versus neurostimulators (n=705) 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-six percent (86.5%) of neurostimulators were InterStim II (n=610), and 13.5% (n=95) were InterStim. The aggregate prospective follow-up time for all neurostimulators was 11,523 months (960 years).

Neurostimulator Events Neurostimulator Events

There were 6 product performance-related events with an underlying reported etiology related to neurostimulator function. All 6 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 14/82 (17%). 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 14 devices that were returned for analysis. The 6 neurostimulators with performance-related events were not returned to Medtronic RPA but were assigned as device-related by the physician as high impedance (n=2), device malfunction (n=2), device electrical impedance issue (n=1), and device battery 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 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. For neurostimulators:

  • 6 had follow-up cut-off due to product performance-related events.
  • 292 were censored in the survival analysis for the following reasons: patient expired, neurostimulator explanted, patient discontinued, therapy suspended, other neurostimulator modification, or non-product performance neurostimulator-related event with no associated intervention.
  • 407 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

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Neurostimulator Characteristics
Model Name InterStim
FDA Approval Date Jul 1998
Neurostimulators Enrolled 95
Neurostimulators Currently Active in Study 61
Device Events 1a
Cumulative Months of Follow-up 2,115

aEvent occurred at 37 months of follow-up.

Model 3023 InterStim: Event Summary Table
Neurostimulator Event Total
Device battery issue 1
Total Neurostimulator Events 1
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 57
2 yrs 100.0% (NA) 44
3 yrs 100.0% (NA)a 24

aEvent occurred at 37 months of follow-up.

 

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

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Neurostimulator Characteristics
Model Name InterStim II
FDA Approval Date Jun 2006
Neurostimulators Enrolled 610
Neurostimulators Currently Active in Study 362
Device Events 5
Cumulative Months of Follow-up 9,409
Model 3058 InterStim II: Event Summary Table
Neurostimulator Event Total
High impedancea 2
Device malfunctionb 2
Device electrical impedance issue 1
Total Neurostimulator Events 5

a Includes 2 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 and 1 neurostimulator malfunction.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.7%
(98.0%, 100.0%)
323
2 yrs 97.9%
(94.9%, 99.2%)
145
3 yrs 97.9%
(94.9%, 99.2%)
54
45 mo 97.9%
(94.9%, 99.2%)
27

 

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
Eventsa
Cumulative
Months of
Follow-up
InterStim InterStim Jul
1998
95 61 1 2,115
InterStim II InterStim Jun
2006
610 362 5 9,409
Device Survival Probability (95% Confidence Interval)
Model Name 1 yr 2 yrs 3 yrs
InterStim 100.0%
NA
100.0%
NA
100.0%
NA
InterStim II 99.7%
(98.0%, 100.0%)
97.9%
(94.9%, 99.2%)
97.9%
(94.9%, 99.2%)

a The event for the InterStim device occurred at 37 months of follow-up, a point beyond which the survival estimates are provided due to a low number of active devices (less than 20).

Leads

From April 2010 to the report cut-off date of July 31, 2016, there were 695 leads followed in the registry. Differences between the total number of leads versus the total number of neurostimulators (N=705) 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 11,314 months (943 years).

A lead is a set of thin wires with a protective coating and electrodes near the tip. The table below provides the number and percentage of leads by model.

Leads by Model
Model Number of Leads (%)
3889 (tined) 604 (86.9%)
Unspecified 2 (0.3%)
Leads No Longer Manufactured
3093 (tined) 85 (12.2%)
3080 3 (0.4%)
3092 1 (0.1%)
Total 695 (100%)

Lead EventsLead Events

There were 57 product performance-related events with an underlying reported etiology related to the lead. This includes 55 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=28). Of the 57 product performance-related lead events, 49 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 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. For leads:

  • 49 had follow-up time cut-off due to product performance-related events.
  • 249 were censored in the survival analysis for the following reasons: patient expired, lead explanted, patient discontinued, other lead modification, therapy suspended, or non-product performance lead-related event without an associated intervention.
  • 397 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

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Lead Characteristics
Model Number 3889
FDA Approval Date Sep 2002
Leads Enrolled 604
Leads Currently Active in Study 375
Device Events 44
Cumulative Months of Follow-up 9,454
Model 3889: Event Summary Table
Lead Event Total
High impedance 22
Lead migration/dislodgement 8
Lead fracture 7
Low impedance 6
Device electrical impedance issue 1
Total Lead Events 44
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 95.2%
(92.6%, 96.9%)
293
2 yrs 89.8%
(85.6%, 92.8%)
139
3 yrs 81.0%
(73.5%, 86.6%)
56
4 yrs 79.4%
(71.1%, 85.5%)
29
at 54 mo 76.0%
(65.0%, 84.0%)
20

 

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

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Lead Characteristics
Model Number 3093
FDA Approval Date Sep 2002
Leads Enrolled 85
Leads Currently Active in Study 41
Device Events 4
Cumulative Months of Follow-up 1,780
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%)
48
2 yrs 93.6%
(81.3%, 97.9%)
29
at 27 mo 93.6%
(81.3%, 97.9%)
25

 

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 604 375 44 9,454
3093 3093 Sep 2002 85 41 4 1,780

a There were 57 lead-related events reported to the registry, but only 48 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=1) 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
3889 95.2%
(92.6%, 96.9%)
89.8%
(85.6%, 92.8%)
81.0%
(73.5%, 86.6%)
79.4%
(71.1%, 85.5%)
3093 98.3%
(88.5%, 99.8%)
93.6%
(81.3%, 97.9%)
- -

Extensions

From April 2010 to the report cut-off date of July 31, 2016, there were 94 extensions followed in the registry. Differences between the total number of extensions versus the total neurostimulators (N=705) were due to the fact that not all systems require an extension.

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). All the extensions were Model 3095. The aggregate prospective follow-up time for all extensions was 2,185 months (182 years).

Extension EventsExtension Events

There were 3 product performance-related events with an underlying reported etiology related to the extension. Of these 3 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 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. For extensions:

  • 1 had follow-up time cut-off due to product performance-related events.
  • 33 were censored in the survival analysis for the following reasons: patient expired, extension explanted, patient discontinued, or therapy suspended.
  • 60 were free from product performance-related events and censoring events and 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

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Extension Characteristics
Model Number 3095
FDA Approval Date Jul 1998
Extensions Enrolled 94
Extensions Currently Active in Study 61
Device Events 1
Cumulative Months of Follow-up 2,185
Model 3095: Event Summary Table
Lead fracturea 1
Total Extension Events 1

aLead fracture attributed to both the lead and extension.

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 56
2 yrs 98.0% (86.8%, 99.7%) 40
at 33 mo 98.0% (86.8%, 99.7%) 24

 

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 94 61 1 2,185
Device Survival Probability (95% Confidence Interval)
Model Number 1 yr 2 yrs
3095 100.0%
NA
98.0%
(86.8%, 99.7%)

a There were a total of 3 extension-related events reported to the registry, but only 1 event included in this summary table. The remaining events were subsequent events (i.e. additional events that occurred after the survival censoring event) that did not affect the device survival estimates.

 

2016 Medtronic Product Performance Report: Data through July 31, 2016.

United States