AXONICS
Report
- Report Number
- 2124215-2025-38231
- Event Type
- Malfunction
- Date Received
- June 13, 2025
- Date of Event
- May 15, 2025
- Report Date
- February 17, 2026
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340141
- PMA / PMN Number
- P180046
- 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. THE INVESTIGATION SHOWED THAT A WIRE WAS STICKING OUT OF THE TINED LEAD. REGARDLESS, THE TINED LEAD IS FULLY FUNCTIONAL, WITH ZERO IMPEDANCES ISSUES SEEN DURING DEVICE TESTING. THE REPORTED DEVICE PERFORMANCE ALLEGATION WAS CONFIRMED AS THE LEAD WIRE WAS STICKING OUT OF THE BODY. BASED ON THE DHR REVIEW, THERE WERE NO ISSUES FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A DEVICE FRACTURE/FAILURE IS AN INHERENT ADVERSE EVENT THAT IS POSSIBLE WITH IMPLANT PROCEDURE. BASED ON THE INFORMATION AVAILABLE A CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. WAS ASSIGNED TO THIS INVESTIGATION.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006. THE INVESTIGATION SHOWED THAT A WIRE WAS STICKING OUT OF THE TINED LEAD. REGARDLESS, THE TINED LEAD IS FULLY FUNCTIONAL, WITH ZERO IMPEDANCES ISSUES SEEN DURING DEVICE TESTING. THE REPORTED DEVICE PERFORMANCE ALLEGATION WAS CONFIRMED AS THE LEAD WIRE WAS STICKING OUT OF THE BODY. BASED ON THE DHR REVIEW, THERE WERE NO ISSUES FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A DEVICE FRACTURE/FAILURE IS AN INHERENT ADVERSE EVENT THAT IS POSSIBLE WITH IMPLANT PROCEDURE. BASED ON THE INFORMATION AVAILABLE A CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. WAS ASSIGNED TO THIS INVESTIGATION.
IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED THE STAGE 2 IMPLANT FOR THE SUBJECT, THE PHYSICIAN NOTICED A LEAD FRACTURE. A FRACTURE WAS NOTED IN THE LEAD COATING WITH EXPOSED WIRE. THE LEAD WAS EXPLANTED, AND A NEW LEAD WAS IMPLANTED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED THE STAGE 2 IMPLANT FOR THE SUBJECT, THE PHYSICIAN NOTICED A LEAD FRACTURE. A FRACTURE WAS NOTED IN THE LEAD COATING WITH EXPOSED WIRE. THE LEAD WAS EXPLANTED, AND A NEW LEAD WAS IMPLANTED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED THE STAGE 2 IMPLANT FOR THE SUBJECT, THE PHYSICIAN NOTICED A LEAD FRACTURE. A FRACTURE WAS NOTED IN THE LEAD COATING WITH EXPOSED WIRE. THE LEAD WAS EXPLANTED, AND A NEW LEAD WAS IMPLANTED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED THE STAGE 2 IMPLANT FOR THE SUBJECT, THE PHYSICIAN NOTICED A LEAD FRACTURE. A FRACTURE WAS NOTED IN THE LEAD COATING WITH EXPOSED WIRE. THE LEAD WAS EXPLANTED, AND A NEW LEAD WAS IMPLANTED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 635830 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | AL1M731028 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |