AXONICS
Report
- Report Number
- 2124215-2025-36378
- Event Type
- Injury
- Date Received
- June 3, 2025
- Date of Event
- May 1, 2025
- Report Date
- September 4, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340066
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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.
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 WAS EXPERIENCING A BUZZING SENSATION WHEN THE DEVICE WAS TURNED OFF. THE DEVICE WAS REMOVED PER PATIENT'S REQUEST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING A BUZZING SENSATION WHEN THE DEVICE WAS TURNED OFF. THE DEVICE WAS REMOVED PER PATIENT'S REQUEST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING A BUZZING SENSATION WHEN THE DEVICE WAS TURNED OFF. THE DEVICE WAS REMOVED PER PATIENT'S REQUEST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING A BUZZING SENSATION WHEN THE DEVICE WAS TURNED OFF. THE DEVICE WAS REMOVED PER PATIENT'S REQUEST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358225 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1101 | AX1G162391 | 10810005340066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | LEAD - AL1T901666.| LEAD - AL1T901666.| LEAD - AL1T901666. |