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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, 2015. Nineteen centers enrolled and contributed patients to the sacral neuromodulation section of the report.


Patients

Of the 639 sacral neuromodulation patients enrolled, the primary indications for implant were as follows: 39.4% were implanted for the treatment of urinary urge incontinence, 34.4% were implanted for the treatment of urgency-frequency, 9.5% were implanted for the treatment of urinary retention, 6.3% were implanted for the treatment of some other indication, 5.9% were implanted for the treatment of fecal incontinence, 2.5% were implanted for the treatment of interstitial cystitis, 1.3% were implanted for the treatment of chronic pelvic pain syndrome, 0.3% were implanted for the treatment of painful bladder syndrome, and 0.3% were implanted for indications that were not specified in the database.

Primary SNM Treatment IndicationsPrimary SNM Treatment Indications

Primary SNM Treatment Indications Chart
 
Primary Treatment Indicationa Total Enrolled Patients (Percent)
Urinary urge incontinence 252 (39.4%)
Urgency-frequency 220 (34.4%)
Urinary retention 61 (9.5%)
Fecal incontinence 38 (5.9%)
Interstitial cystitis 16 (2.5%)
Chronic pelvic pain syndrome 8 (1.3%)
Painful bladder syndrome 2 (0.3%)
Other 40 (6.3%)
Not specified 2 (0.3%)
Total Patients 639

a Refer to product labeling for approved indications.

 

Event Summary

There were 245 events reported between April 2010 and July 31, 2015 in patients with sacral neuromodulation systems. Of these events, 26.1% (64/245) were categorized as product performance-related and are presented graphically within this report. The 64 product performance events occurred in 43 of the 639 total patients (6.73%) enrolled. In addition, there were 181 non-product performance events reported. There were also 11 deaths reported for patients with sacral neuromodulation systems, none of which were reported as a direct result of a device-related event or the stimulation therapy.

Sacral Neuromodulation System Product Performance Events
Eventa Number of Product
Performance
Events
Number of Patients with Event Percent of Patients with Event
(n=639)
Lead high impedance 31 21 3.29%
Lead migration/dislodgment 13 9 1.41%
Lead fracture 6 6 0.94%
Device battery issue 4 1 0.16%
Lead low impedance 3 3 0.47%
Device electrical impedance issue 2 1 0.16%
Device lead issue 2 1 0.16%
Device lead damage 1 1 0.16%
Device malfunctionb 1 1 0.16%
Device telemetry issue 1 1 0.16%
Total 64 43 6.73%

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 Reported as device function could not be recovered after a fall.

A total of 40 (62.5%) of the 64 product performance events were related to the lead, 12 (18.8%) were related to “multiple etiologies”, which includes events where at least one device and one non-device etiology was indicated, 4 (6.3%) were related to the extension, 4 (6.3%) were related to the neurostimulator, 2 (3.1%) were related to other devices, 1 (1.6%) was related to other etiology, and 1 (1.6%) was related to programming/stimulation. Relatedness is determined by the physician.

Product Performance Events by Relatedness

 

 

 

Product Performance Events by Relatedness  

 

 

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 65
   Urinary tract infectionc 51
   Implant site infection 8
   Incision site infection 2
   Wound infection 2
   Infection 1
   Postoperative wound infection 1
Administration site reactions 23
   Implant site pain 22
   Implant site erythema 1
Therapeutic and nontherapeutic effects (excluding toxicity) 25
   Therapeutic product ineffective 24
   Therapeutic response decreased 1
Device issues 18
   Device stimulation issue 12
   Neurostimulator migration 3
   Neurostimulator inversion 2
   Device extrusion 1
Neurological disorders not elsewhere classified (NEC) 9
   Paraesthesia 7
   Restless legs syndrome 1
   Sensory disturbance 1
Urinary tract signs and symptoms 8
   Urinary incontinence 3
   Bladder pain 1
   Micturition urgency 1
   Nocturia 1
   Urge incontinence 1
   Urinary retention 1
General system disorders NEC 7
   Pain 3
   No anomaly found by RPAd 2
   Oedema 1
   Sensation of pressure 1
Therapeutic procedures and supportive care NEC 4
   Incisional drainage 3
   Wound drainage 1
Injuries NEC 2
   Electric shock 1
   Wound 1
Bacterial infectious disorders 4
   Cellulitis 1
   Implant site cellulitis 1
   Staphylococcal infection 2
Reproductive tract disorders NEC 2
   Pelvic pain 2
Anal and rectal conditions NEC 1
   Proctalgia 1
Bladder and bladder neck disorders (excluding calculi) 1
   Cystitis 1
Bone disorders (excluding congenital and fractures) 1
   Bone pain 1
Complications associated with device 1
   Medical device discomfort 1
Epidermal and dermal conditions 1
   Skin reaction 1
Genitourinary tract disorders NEC 1
   Urinary tract disorder 1
Joint disorders 1
   Arthralgia 1
Musculoskeletal and connective tissue disorders NEC 1
   Pain in extremity 1
Procedural related injuries and complications NEC 1
   Procedural complication 1
Vulvovaginal disorders (excluding infections and inflammations) 1
   Vulvovaginal pain 1
Not Codede 4
Totals 181

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.
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).
e Events that had not been MedDRA-coded at the time of the report cut-off.

There were 11 deaths reported for patients with sacral neuromodulation systems, none of which were reported as a direct result of a device-related event or the stimulation therapy. Five deaths occurred in patients receiving therapy for urgency-frequency, 3 deaths for other indications, 2 deaths for urinary urge incontinence and 1 for urinary retention.

Death by Primary Indication
Primary Indicationa N (%)
Urgency-frequency 5 (45.5%)
Otherb 3 (27.3%)
Urinary urge incontinence 2 (18.2%)
Urinary retention 1 (9.1%)
Total 11 (100%)

a Refer to product labeling for approved indications
b Includes 1 indication of atony of bladder, 1 of neurogenic bladder and 1 of urinary tract infection

Neurostimulators

From April 2010 to the report cut-off date of July 31, 2015, 598 neurostimulators were followed in the registry. The difference between the total number of patients (n=639) versus neurostimulators (n=598) 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-four percent (84.8%) of neurostimulators were InterStim II (n=507), and 15.2% (n=91) were InterStim. The aggregate prospective follow-up time for all neurostimulators was 8,003 months (667 years).

Neurostimulator Events Neurostimulator Events

There were 6 product performance-related events with an underlying reported etiology related to neurostimulator function. This includes 4 events with a neurostimulator etiology and 2 events with both a stimulator and other etiology (including device and non-device etiologies). Of these 6 product performance events, 5 were the first event attributable to an enrolled neurostimulator. For neurostimulators in the registry, the current return rate to Medtronic Returned Product Analysis (RPA) was 10/55 (18%). 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 10 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 lead high impedance (n=3), device malfunction (n=1), 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:

  • 5 had follow-up cut-off due to product performance-related events.
  • 208 were censored in the survival analysis for the following reasons: patient expired, stimulator explanted, patient discontinued, therapy suspended, other stimulator modification, or non-product performance stimulator-related event with no associated intervention.
  • 385 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 91
Neurostimulators Currently Active in Study 60
Device Events 1a
Cumulative Months of Follow-up 1,625
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) 49
2 yrs 100.0% (NA) 29
at 27 mo 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)
Thinness 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 507
Neurostimulators Currently Active in Study 337
Device Events 4
Cumulative Months of Follow-up 6,378
Model 3058 InterStim II: Event Summary Table
Neurostimulator Event Total
Lead high impedancea 2
Device malfunctionb 1
Device electrical impedance issue 1
Total Neurostimulator Events 4

a Includes 2 events reported as high impedance of both lead and neurostimulator
b Reported as device function could not be restored after a fall

Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 99.5%
(96.7%, 99.9%)
182
2 yrs 98.1%
(93.9%, 99.4%)
77
3 yrs 98.1%
(93.9%, 99.4%)
25

 

Model 3058 InterStim II: Specifications

Height 1.7 in (44 mm) Model 3058 InterStim II
Width 2.0 in (51 mm)
Thinness 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
91 60 1 1,625
InterStim II InterStim Jun
2006
507 337 4 6,378
Device Survival Probability (95% Confidence Interval)
Model Name 1 yr 2 yrs 3 yrs
InterStim 100.0%
NA
100.0%
NA
-
InterStim II 99.5%
(96.7%, 99.9%)
98.1%
(93.9%, 99.4%)
98.1%
(93.9%, 99.4%)

a There were a total of 6 neurostimulator-related events reported to the registry, but only 5 events included in this summary table. The remaining event was a subsequent device event that did not affect the survival estimates.

Leads

From April 2010 to the report cut-off date of July 31, 2015, there were 595 leads followed in the registry. Differences between the total number of leads versus the total number of neurostimulators (N=598) 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 7,856 months (655 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 Number of Leads (%)
3889 507 (85.2%)
3093 83 (13.9%)
3080 3 (0.5%)
3092 1 (0.2%)
Unspecified 1 (0.2%)
Total 595 (100%)

Lead EventsLead Events

There were 44 product performance-related events with an underlying reported etiology related to the lead. This includes 40 events with a lead etiology and 4 events with both a lead and other etiology (including device and non-device etiologies). The majority of the events were lead high impedance (n=23). Of the 44 product performance-related lead events, 36 were the first event attributable to an enrolled lead.

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:

  • 36 had follow-up time cut-off due to product performance-related events.
  • 179 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.
  • 380 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 507
Leads Currently Active in Study 345
Device Events 32
Cumulative Months of Follow-up 6,412
Model 3889: Event Summary Table
Lead Event Total
Lead high impedance 18
Lead fracture 5
Lead migration/dislodgment 5
Lead low impedance 3
Device electrical impedance issue 1
Total Lead Events 32
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 94.7%
(91.2%, 96.9%)
171
2 yrs 88.7%
(82.8%, 92.7%)
79
3 yrs 75.2%
(62.6%, 84.1%)
25
at 39 mo 75.2%
(62.6%, 84.1%)
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 83
Leads Currently Active in Study 47
Device Events 3
Cumulative Months of Follow-up 1,387
Model 3093: Event Summary Table
Lead Event Total
Lead migration/dislodgment 1
Lead fracture 1
Device lead damage 1
Total Lead Events 3
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 97.9%
(86.0%, 99.7%)
34
at 15 mo 94.7%
(79.8%, 98.7%)
29

 

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 507 345 32 6,412
3093 3093 Sep 2002 83 47 3 1,387

a There were 44 lead-related events reported to the registry, but only 35 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 (ie, Model 3080) (n=1) or were subsequent events that did not affect the device survival estimates.

Device Survival Probability (95% Confidence Interval)
Model
Number
Family 1 yr 2 yrs 3 yrs
3889 3889 94.7%
(91.2%, 96.9%)
88.7%
(82.8%, 92.7%)
75.2%
(62.6%, 84.1%)
3093 3093 97.9%
(86.0%, 99.7%)
- -

Extensions

From April 2010 to the report cut-off date of July 31, 2015, there were 92 extensions followed in the registry. Differences between the total number of extensions versus the total neurostimulators (N=598) 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 1,656 months (138 years).

Extension EventsExtension Events

There were 7 product performance-related events with an underlying reported etiology related to the extension, however, none of these could be attributed to an extension model because data needed to associate the event to the model was missing at the time of the data cut-off for this report. Of these 7 events, 4 had an extension etiology, and 3 had both an extension and other etiology (including device and non-device).

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:

  • 0 had follow-up time cut-off due to product performance-related events
  • 31 were censored in the survival analysis for the following reasons: patient expired, extension explanted, patient discontinued, or therapy suspended.
  • 61 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

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Extension Characteristics
Model Number 3095
FDA Approval Date Jul 1998
Extensions Enrolled 92
Extensions Currently Active in Study 61
Device Events 0
Cumulative Months of Follow-up 1,656
Time Interval Survival
(95% Confidence Interval)
Sample Size
1 yr 100.0% (NA) 45
2 yrs 100.0% (NA) 26
at 27 mo 100.0% (NA) 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 92 61 0 1,656
Device Survival Probability (95% Confidence Interval)
Model Number 1 yr 2 yrs
3095 100.0%
NA
100.0%
NA

a There were 7 product performance-related events with an underlying reported etiology related to the extension, however, none of these could be attributed to an extension model because data needed to associate the event to the model was missing at the time of the data cut-off for this report.

 

2015 Medtronic Product Performance Report: Data through July 31, 2015

United States