AXONICS
Report
- Report Number
- 2124215-2025-36377
- Event Type
- Injury
- Date Received
- June 3, 2025
- Date of Event
- May 12, 2025
- Report Date
- August 21, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340141
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.
ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.
ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.
IT WAS REPORTED THAT DURING AN EXTERNAL NEUROSTIMULATOR PROCEDURE, THE PATIENT HAD A REACTION TO THE MEDICATION GIVEN. IT WAS NOTED THAT THE PHYSICIAN COULD NOT FIND THE OPENING OF THE FORAMEN FOR THE LEAD DUE TO PATIENT ANATOMY. THE PATIENT HAD TWO 'SEIZURE LIKE' EPISODES AND THE PHYSICIAN DID NOT WANT TO PROCEED. THE CASE WAS ABORTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT DURING AN EXTERNAL NEUROSTIMULATOR PROCEDURE, THE PATIENT HAD A REACTION TO THE MEDICATION GIVEN. IT WAS NOTED THAT THE PHYSICIAN COULD NOT FIND THE OPENING OF THE FORAMEN FOR THE LEAD DUE TO PATIENT ANATOMY. THE PATIENT HAD TWO 'SEIZURE LIKE' EPISODES AND THE PHYSICIAN DID NOT WANT TO PROCEED. THE CASE WAS ABORTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT DURING AN EXTERNAL NEUROSTIMULATOR PROCEDURE, THE PATIENT HAD A REACTION TO THE MEDICATION GIVEN. IT WAS NOTED THAT THE PHYSICIAN COULD NOT FIND THE OPENING OF THE FORAMEN FOR THE LEAD DUE TO PATIENT ANATOMY. THE PATIENT HAD TWO 'SEIZURE LIKE' EPISODES AND THE PHYSICIAN DID NOT WANT TO PROCEED. THE CASE WAS ABORTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358248 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | AL1N143596 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Other | PERCUTANEOUS EXTENSION 9009, (B)(6).| PERCUTANEOUS EXTENSION 9009, (B)(6).| PERCUTANEOUS EXTENSION 9009, (B)(6).| TRIAL STIMULATOR 1601, (B)(6).| TRIAL STIMULATOR 1601, (B)(6).| TRIAL STIMULATOR 1601, (B)(6). |