Devices › Stimulator, electrical, implantable, for incontinence
Device brand name · Stimulator electrical implantable for incontinence
Axonics: medical device reports filed with FDA
2,360 reports name it, 2020–2026. Manufacturer given most often on reports: Axonics Modulation Technologies. Product code EZW.
- 2,360
- device reports naming the brand
- 0% of all MAUDE reports · about 363 a year
- 1,069
- reports, 12 months to August 2026
- 690 in the 12 months before
- 13%
- classified as malfunction
- 50.7% across the product code
- 0.1%
- classified as death, as reported
- 3 reports · not verified by FDA
2,360 medical device reports received by FDA name the brand "Axonics" (stimulator electrical implantable for incontinence); the manufacturer given most often on reports is Axonics Modulation Technologies; received from January 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,069 reports arrived in the 12 months to August 2026, up 55% from 690 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 (86.8%), malfunction (13%) and death (0.1%); 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 (20.9%), high impedance (10%) and communication or transmission problem (4.8%). 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 |
|---|---|---|---|
| Migrationthe device moved from where it was placed | 493 | 20.9% | 0.6% |
| High impedance | 237 | 10% | 5.1% |
| Communication or transmission problemthe device could not communicate or transmit | 114 | 4.8% | 5.8% |
| Lack of effect | 97 | 4.1% | 0.1% |
| Fracturea broken bone | 85 | 3.6% | 0.3% |
| Impedance problem | 70 | 3% | 1.4% |
| Charging problem | 68 | 2.9% | 1.2% |
| Failure to charge | 53 | 2.2% | 0.1% |
| Unexpected therapeutic results | 35 | 1.5% | 0.8% |
| Material integrity problema problem with the device material | 29 | 1.2% | 0.1% |
| Breakthe device broke | 24 | 1% | 5.7% |
| Nonstandard device | 23 | 1% | 0% |
| Material twisted/bent | 21 | 0.9% | 0.1% |
| Disconnection | 20 | 0.8% | 0.8% |
| Premature discharge of battery | 19 | 0.8% | 1.3% |
| Defective devicethe device was defective | 18 | 0.8% | 0% |
| Device displays incorrect message | 16 | 0.7% | 3.2% |
| Malposition of device | 14 | 0.6% | 2.7% |
| Insufficient device problem information | 13 | 0.6% | 13.9% |
| Inappropriate/inadequate shock/stimulation | 9 | 0.4% | 9.3% |
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 | 401 | 17% |
| Incontinence | 388 | 16.4% |
| Discomfortdiscomfort | 323 | 13.7% |
| Implant pain | 248 | 10.5% |
| Failure of implant | 232 | 9.8% |
| Undesired nerve stimulation | 156 | 6.6% |
| Urinary incontinenceleaking urine | 156 | 6.6% |
| Urinary tract infectionbladder or urinary infection | 130 | 5.5% |
| Inappropriate device stimulation of tissue | 103 | 4.4% |
| Urinary frequency / polyuria | 78 | 3.3% |
| Wound dehiscencea wound reopened | 57 | 2.4% |
| Pocket erosion | 49 | 2.1% |
| Micturition urgency | 44 | 1.9% |
| Urinary retentionbeing unable to empty the bladder | 43 | 1.8% |
| Fecal incontinence | 42 | 1.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Axonics | Product code EZW | All MAUDE reports |
|---|---|---|---|
| Reports | 2,360 | 83,156 | 26,136,888 |
| Share of that pool | — | 2.8% | 0% |
| Classified as death, per 1,000 reports | 1 | 1 | 9 |
| Classified as injury | 86.8% | 48.9% | 36.2% |
| Classified as malfunction | 13% | 50.7% | 62.3% |
| Filed by the manufacturer | 99.7% | 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% |
| 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 Axonics reports
How many FDA reports name Axonics?
2,360 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,069 in the latest 12 months.
What kinds of events are reported?
injury (86.8%), malfunction (13%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (20.9%), high impedance (10%), communication or transmission problem (4.8%), lack of effect (4.1%) and fracture (3.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Axonics 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.