AXONICS
Report
- Report Number
- 2124215-2025-35190
- Event Type
- Injury
- Date Received
- June 3, 2025
- Date of Event
- May 1, 2025
- Report Date
- July 9, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340455
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3 DATE OF EVENT: UNKNOWN, USED THE FIRST DAY OF THE AWARE MONTH. ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.
B3 DATE OF EVENT: UNKNOWN, USED THE FIRST DAY OF THE AWARE MONTH ADDITIONAL PRODUCT CODE: QON ADDITIONAL PREMARKET/510K: P190006.
B3 DATE OF EVENT: UNKNOWN, USED THE FIRST DAY OF THE AWARE MONTH. ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR DID NOT HAVE ANY RELIEF WITH THE DEVICE. THE NEUROSTIMULATOR SYSTEM WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR DID NOT HAVE ANY RELIEF WITH THE DEVICE. THE NEUROSTIMULATOR SYSTEM WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR DID NOT HAVE ANY RELIEF WITH THE DEVICE. THE NEUROSTIMULATOR SYSTEM WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1066029 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | AX1T013440 | 10810005340455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Unknown | Hospitalization| R |