AXONICS
Report
- Report Number
- 2124215-2025-38250
- Event Type
- Injury
- Date Received
- June 13, 2025
- Date of Event
- May 8, 2025
- Report Date
- September 21, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
IT WAS REPORTED THAT THE PATIENT HAD A RED LIGHT ON THE BOTTOM OF THEIR REMOTE. THE PATIENT HAD AN IN-OFFICE VISIT TO GET THEIR ELECTRODES CHECK AND AN X-RAY OR POTENTIAL REVISION IS THE NEXT COURSE OF ACTION. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2025; HOWEVER, IT HAS NOT BEEN CONFIRMED IF THE REVISION OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT HAD A RED LIGHT ON THE BOTTOM OF THEIR REMOTE. THE PATIENT HAD AN IN-OFFICE VISIT TO GET THEIR ELECTRODES CHECK AND AN X-RAY OR POTENTIAL REVISION WAS THE NEXT COURSE OF ACTION. A REVISION PROCEDURE OCCURRED AND THE PATIENT IS DOING WELL. THE PATIENT IS WORKING WELL WITH THE SETTINGS AND THE REPRESENTATIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT HAD A RED LIGHT ON THE BOTTOM OF THEIR REMOTE. THE PATIENT HAD AN IN-OFFICE VISIT TO GET THEIR ELECTRODES CHECK AND AN X-RAY OR POTENTIAL REVISION WAS THE NEXT COURSE OF ACTION. A REVISION PROCEDURE OCCURRED AND THE PATIENT IS DOING WELL. THE PATIENT IS WORKING WELL WITH THE SETTINGS AND THE REPRESENTATIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT THE PATIENT HAD A RED LIGHT ON THE BOTTOM OF THEIR REMOTE. THE PATIENT HAD AN IN-OFFICE VISIT TO GET THEIR ELECTRODES CHECK AND AN X-RAY OR POTENTIAL REVISION WAS THE NEXT COURSE OF ACTION. A REVISION PROCEDURE OCCURRED AND THE PATIENT IS DOING WELL. THE PATIENT IS WORKING WELL WITH THE SETTINGS AND THE REPRESENTATIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376204 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | AL1R542517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention| H |