AXONICS
Report
- Report Number
- 2124215-2025-55574
- Event Type
- Malfunction
- Date Received
- August 15, 2025
- Date of Event
- July 22, 2025
- Report Date
- December 30, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340479
- PMA / PMN Number
- P180046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET/510(K) # (G4) - ADDITIONAL PREMARKET/510(K) P190006. CORRECTION: H6 DEVICE CODE.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET/510(K) P190006.
IT WAS REPORTED THAT PRIOR TO A FULL IMPLANT PROCEDURE, THE REPRESENTATIVE VISUALLY INSPECTED THE PRODUCT AND FOUND A 2MM SPECK OF FOREIGN MATERIAL INSIDE THE STERILE PACKAGING. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT, AND THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT PRIOR TO A FULL IMPLANT PROCEDURE, THE REPRESENTATIVE VISUALLY INSPECTED THE PRODUCT AND FOUND A 2MM SPECK OF FOREIGN MATERIAL INSIDE THE STERILE PACKAGING. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT, AND THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1240566 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 5101 | AX1G196585 | 10810005340479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |