AXONICS
Report
- Report Number
- 2124215-2025-39629
- Event Type
- Injury
- Date Received
- June 24, 2025
- Date of Event
- May 14, 2025
- Report Date
- March 11, 2026
- 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
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006. ADDITIONAL INFORMATION: INITIAL REPORTER, SECTION E, ADDED.
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 DEVICE WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE IPG REVEALED NO ABNORMALITIES. THERE WERE NO ERROR CODES DETECTED IN THE LOGS OR REPORTED BY IPGLINK. THE IPG PASSED THE IMPEDANCE CHECK WITH A TEST TINED LEAD. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. THERE WERE ZERO ISSUES FOUND WITH IPG DURING INSPECTION, THEREFORE NO PROBLEM DETECTED WAS CHOSEN AS THE CONCLUSION CODE.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006. THE DEVICE WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE IPG REVEALED NO ABNORMALITIES. THERE WERE NO ERROR CODES DETECTED IN THE LOGS OR REPORTED BY IPGLINK. THE IPG PASSED THE IMPEDANCE CHECK WITH A TEST TINED LEAD. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. THERE WERE ZERO ISSUES FOUND WITH IPG DURING INSPECTION, THEREFORE NO PROBLEM DETECTED WAS CHOSEN AS THE CONCLUSION CODE.
IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE EXPLANTED DUE TO LACK OF EFFECT. THE LEAD WAS CUT INTO TWO PIECES WITH A LEAD-LOCKING DEVICE (TO REMOVE THE DEVICE) ATTACHED TO IT. IT IS ASSUMED THAT THE PATIENT IS DOING FINE AS THERE WAS NO FOLLOW UP. THE PATIENT NEVER RECEIVED THERAPY FROM THE DEVICE.
IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE EXPLANTED DUE TO LACK OF EFFECT. THE LEAD WAS CUT INTO TWO PIECES WITH A LEAD-LOCKING DEVICE (TO REMOVE THE DEVICE) ATTACHED TO IT.
IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE EXPLANTED DUE TO LACK OF EFFECT. THE LEAD WAS CUT INTO TWO PIECES WITH A LEAD-LOCKING DEVICE (TO REMOVE THE DEVICE) ATTACHED TO IT. IT IS ASSUMED THAT THE PATIENT IS DOING FINE AS THERE WAS NO FOLLOW UP. THE PATIENT NEVER RECEIVED THERAPY FROM THE DEVICE.
IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE EXPLANTED DUE TO LACK OF EFFECT. THE LEAD WAS CUT INTO TWO PIECES WITH A LEAD-LOCKING DEVICE (TO REMOVE THE DEVICE) ATTACHED TO IT. IT IS ASSUMED THAT THE PATIENT IS DOING FINE AS THERE WAS NO FOLLOW UP. THE PATIENT NEVER RECEIVED THERAPY FROM THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1998523 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1101 | AX1G159574 | 10810005340066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |