AXONICS
Report
- Report Number
- 2124215-2026-01735
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- December 11, 2025
- Report Date
- March 5, 2026
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340141
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006 UDI FOR CONCOMITANT PRODUCT, NEUROSTIMULATOR: (B)(4).
BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON. BLOCK G4: PREMARKET / 510(K) #: ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, NEUROSTIMULATOR: (B)(4). BLOCK H11: INVESTIGATION DETAILS: THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. SINCE THE INVESTIGATION FINDINGS DO NOT CLEARLY CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE, THE INVESTIGATION CONCLUSION CODE SELECTED FOR THIS COMPLAINT IS UNABLE TO EXCLUDE DEVICE PROBLEM.
IT WAS REPORTED THE PATIENT HAD SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD. THE PATIENT REPORTED A RED LIGHT ON THEIR REMOTE CONTROL, AND IT WAS DISCOVERED THEIR TINED LEAD HAD DISCONNECTED. AN X-RAY WAS ORDERED, AND IT SHOWED THE TINED LEAD HAD FRACTURED. THE PATIENT IS EXPECTED TO FULLY RECOVER FROM THE EXPLANT PROCEDURE. THERE IS NO FURTHER INFORMATION POST-EXPLANT.
IT WAS REPORTED THE PATIENT HAD SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD. THE PATIENT REPORTED A RED LIGHT ON THEIR REMOTE CONTROL, AND IT WAS DISCOVERED THEIR TINED LEAD HAD DISCONNECTED. AN X-RAY WAS ORDERED, AND IT SHOWED THE TINED LEAD HAD FRACTURED. THE PATIENT IS EXPECTED TO FULLY RECOVER FROM THE EXPLANT PROCEDURE. THERE IS NO FURTHER INFORMATION POST-EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97125 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | AL1R443239 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Hospitalization| R | NEUROSTIMULATOR, 4101, (B)(6).| NEUROSTIMULATOR, 4101, (B)(6). |