Devices › Stimulator, electrical, implantable, for incontinence
Device brand name · Stimulator electrical implantable for incontinence
Unknown External Neurostimulator: medical device reports filed with FDA
724 reports name it, 2012–2019. Manufacturer given most often on reports: Medtronic Neuromodulation. Product code EZW.
- 724
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 48.1%
- classified as malfunction
- 50.7% across the product code
- 1.1%
- classified as death, as reported
- 8 reports · not verified by FDA
FDA's MAUDE database holds 724 reports that name the brand "Unknown External Neurostimulator" (stimulator electrical implantable for incontinence), received between January 2012 and September 2019; the manufacturer given most often on reports is Medtronic Neuromodulation. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (50.8%), malfunction (48.1%) and death (1.1%); across all stimulator, electrical, implantable, for incontinence reports (product code EZW) death is recorded in 0.1% and malfunction in 50.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (21.8%), device operates differently than expected (21%) and high impedance (14.4%). The patient problems coded most often are therapeutic effects, unexpected, pain and complaint, ill-defined. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Unknown External Neurostimulator was received in the five years to August 2026; the latest was received in September 2019.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 83,156 reports carrying product code EZW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Migration or expulsion of device | 158 | 21.8% | 11.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 152 | 21% | 17.9% |
| High impedance | 104 | 14.4% | 5.1% |
| Failure to deliver energy | 73 | 10.1% | 13% |
| Breakthe device broke | 48 | 6.6% | 5.7% |
| Inappropriate/inadequate shock/stimulation | 36 | 5% | 9.3% |
| Therapy delivered to incorrect body area | 28 | 3.9% | 4.5% |
| Impedance problem | 18 | 2.5% | 1.4% |
| Device displays incorrect message | 17 | 2.3% | 3.2% |
| Low impedance | 17 | 2.3% | 0.6% |
| Positioning problem | 14 | 1.9% | 1.1% |
| Intermittent continuity | 10 | 1.4% | 2.5% |
| Insufficient device problem information | 8 | 1.1% | 13.9% |
| Device damaged prior to receipt by user | 7 | 1% | 0.2% |
| Connection problema connection problem | 6 | 0.8% | 1.5% |
| Device or device fragments location unknown | 4 | 0.6% | 1% |
| Environmental compatibility problem | 4 | 0.6% | 0.3% |
| Malposition of device | 4 | 0.6% | 2.7% |
| Overheating of device | 4 | 0.6% | 1.4% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 0.4% | 5.8% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Therapeutic effects, unexpected | 141 | 19.5% |
| Painpain, site not specified | 126 | 17.4% |
| Complaint, ill-defined | 59 | 8.1% |
| Discomfortdiscomfort | 47 | 6.5% |
| Urinary retentionbeing unable to empty the bladder | 39 | 5.4% |
| Therapeutic response, decreased | 35 | 4.8% |
| Electric shockan electric shock | 33 | 4.6% |
| Urinary tract infectionbladder or urinary infection | 31 | 4.3% |
| Undesired nerve stimulation | 27 | 3.7% |
| Hemorrhage/blood loss/bleeding | 24 | 3.3% |
| Incontinence | 17 | 2.3% |
| Burning sensationa burning feeling | 15 | 2.1% |
| Erythemaskin redness | 14 | 1.9% |
| Urinary frequency / polyuria | 14 | 1.9% |
| Hematomaa collection of blood under the skin or in tissue | 13 | 1.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown External Neurostimulator | Product code EZW | All MAUDE reports |
|---|---|---|---|
| Reports | 724 | 83,156 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 11 | 1 | 9 |
| Classified as injury | 50.8% | 48.9% | 36.2% |
| Classified as malfunction | 48.1% | 50.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code EZW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Interstim | 11,298 | 1,522 | 0.2% |
| InterStim X | 9,333 | 3,163 | 0% |
| Verify Enhanced | 3,829 | 295 | 0% |
| Verify | 2,413 | 8 | 0% |
| Axonics | 2,360 | 1,069 | 0.1% |
| Implantable Neurostimulator | 6,395 | 692 | 0.3% |
| Unknown Implantable Neurostimulator | 3,843 | 0 | 2.2% |
| External Neurostimulator | 1,227 | 102 | 0.4% |
| SureScan | 33,123 | 490 | 0% |
| Unknown Neurostimulator | 474 | 0 | 1.7% |
| Lead | 1,234 | 118 | 0.5% |
| Synergy | 14,271 | 84 | 3.5% |
| Neu Ins Stimulator | 335 | 0 | 2.1% |
| Unknown Lead | 160 | 0 | 2.5% |
| Itrel | 264 | 0 | 3.4% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Unknown External Neurostimulator reports
How many FDA reports name Unknown External Neurostimulator?
724 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (50.8%), malfunction (48.1%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (21.8%), device operates differently than expected (21%), high impedance (14.4%), failure to deliver energy (10.1%) and break (6.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown External Neurostimulator was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.