FDA Adverse Event
Injury
Summary report: N
AXONICS
MDR report key: 24166453
·
Received January 23, 2026
Report
- Report Number
- 2124215-2026-04324
- Event Type
- Injury
- Date Received
- January 23, 2026
- Date of Event
- December 11, 2025
- Report Date
- May 8, 2026
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340455
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4).
Additional Manufacturer Narrative · 0
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET/510(K) # (G4) - ADDITIONAL PREMARKET/510(K) # P190006.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD THEIR DEVICE EXPLANTED DUE TO NOT RESPONDING TO THE THERAPY. THERE WERE NO PATIENT COMPLICATIONS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD THEIR DEVICE EXPLANTED DUE TO NOT RESPONDING TO THE THERAPY. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166158 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | AX1T008825 | 10810005340455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |