Devices › Stimulator, electrical, implantable, for incontinence
Device brand name · Stimulator electrical implantable for incon
InterStim X: medical device reports filed with FDA
9,333 reports name it, 2022–2026. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code EZW.
- 9,333
- device reports naming the brand
- 0% of all MAUDE reports · about 2,155 a year
- 3,163
- reports, 12 months to August 2026
- 2,900 in the 12 months before
- 55.1%
- classified as malfunction
- 50.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 9,333 reports that name the brand "InterStim X" (stimulator electrical implantable for incon), received between March 2022 and August 2026; the manufacturer given most often on reports is Medtronic Puerto Rico Operations. Spellings of one product vary from report to report.
3,163 reports arrived in the 12 months to August 2026, close to the 2,900 of 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 malfunction (55.1%) and injury (44.9%); 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 insufficient device problem information (21.1%), migration or expulsion of device (14.5%) and energy output problem (14%). The patient problems coded most often are pain, incontinence and discomfort. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Insufficient device problem information | 1,967 | 21.1% | 13.9% |
| Migration or expulsion of device | 1,354 | 14.5% | 11.5% |
| Energy output problem | 1,306 | 14% | 5.1% |
| Failure to deliver energy | 1,189 | 12.7% | 13% |
| Inappropriate/inadequate shock/stimulation | 1,050 | 11.3% | 9.3% |
| Electromagnetic compatibility problem | 759 | 8.1% | 4.8% |
| Unintended collision | 669 | 7.2% | 6.3% |
| High impedance | 644 | 6.9% | 5.1% |
| Therapy delivered to incorrect body area | 625 | 6.7% | 4.5% |
| Communication or transmission problemthe device could not communicate or transmit | 620 | 6.6% | 5.8% |
| Electromagnetic interference | 516 | 5.5% | 4% |
| Malposition of device | 445 | 4.8% | 2.7% |
| Failure to interrogate | 443 | 4.7% | 3.8% |
| Patient device interaction problem | 433 | 4.6% | 1.8% |
| Breakthe device broke | 286 | 3.1% | 5.7% |
| Intermittent continuity | 285 | 3.1% | 2.5% |
| Therapeutic or diagnostic output failure | 285 | 3.1% | 0.6% |
| Premature discharge of battery | 283 | 3% | 1.3% |
| Data problem | 269 | 2.9% | 0.8% |
| Overheating of device | 205 | 2.2% | 1.4% |
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 |
|---|---|---|
| Painpain, site not specified | 2,114 | 22.7% |
| Incontinence | 1,618 | 17.3% |
| Discomfortdiscomfort | 1,074 | 11.5% |
| Electric shockan electric shock | 1,038 | 11.1% |
| Urinary frequency / polyuria | 914 | 9.8% |
| Urinary retentionbeing unable to empty the bladder | 838 | 9% |
| Undesired nerve stimulation | 574 | 6.2% |
| Urinary incontinenceleaking urine | 416 | 4.5% |
| Micturition urgency | 397 | 4.3% |
| Burning sensationa burning feeling | 352 | 3.8% |
| Device overstimulation of tissue | 337 | 3.6% |
| Sleep dysfunction | 297 | 3.2% |
| Ambulation or postural difficulties | 216 | 2.3% |
| Urinary tract infectionbladder or urinary infection | 189 | 2% |
| Swelling/ edema | 175 | 1.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | InterStim X | Product code EZW | All MAUDE reports |
|---|---|---|---|
| Reports | 9,333 | 83,156 | 26,136,888 |
| Share of that pool | — | 11.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 44.9% | 48.9% | 36.2% |
| Classified as malfunction | 55.1% | 50.7% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| 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% |
| Unknown External Neurostimulator | 724 | 0 | 1.1% |
| 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 InterStim X reports
How many FDA reports name InterStim X?
9,333 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3,163 in the latest 12 months.
What kinds of events are reported?
malfunction (55.1%) and injury (44.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (21.1%), migration or expulsion of device (14.5%), energy output problem (14%), failure to deliver energy (12.7%) and inappropriate/inadequate shock/stimulation (11.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that InterStim X 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.