AXONICS
Report
- Report Number
- 2124215-2025-36499
- Event Type
- Malfunction
- Date Received
- June 3, 2025
- Date of Event
- May 1, 2025
- Report Date
- November 30, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340455
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT (B3) WAS NOT REPORTED; THEREFORE, AN ESTIMATED DATE WAS REPORTED IN THIS FIELD. PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
THE FOLLOWING FIELDS HAVE BEEN CORRECTED: H6 DEVICE CODES DATE OF EVENT (B3) WAS NOT REPORTED; THEREFORE, AN ESTIMATED DATE WAS REPORTED IN THIS FIELD. PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
THE FOLLOWING FIELDS HAVE BEEN CORRECTED: H6 IMPACT CODES. DATE OF EVENT (B3) WAS NOT REPORTED; THEREFORE, AN ESTIMATED DATE WAS REPORTED IN THIS FIELD. PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE, THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED; A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.
THE FOLLOWING FIELDS HAVE BEEN CORRECTED: H6 DEVICE CODES. DATE OF EVENT (B3) WAS NOT REPORTED; THEREFORE, AN ESTIMATED DATE WAS REPORTED IN THIS FIELD. PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
THE FOLLOWING FIELDS HAVE BEEN CORRECTED: H6 DEVICE CODES DATE OF EVENT (B3) WAS NOT REPORTED; THEREFORE, AN ESTIMATED DATE WAS REPORTED IN THIS FIELD. PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006.
IT WAS REPORTED THAT THE PATIENT OBSERVED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOTE DISPLAY A RED LIGHT. THE PATIENT PRESENTED TO CLINIC FOR TROUBLESHOOTING AND WHEN CONNECTED TO THE CLINICIAN PROGRAMMER, THE INS DISPLAYED HIGH IMPEDANCE MEASUREMENTS ON ALL FOUR ELECTRODES. DESPITE CHANGING PROGRAMS, MEASUREMENTS REMAINED HIGH SO A REVISION PROCEDURE WAS SCHEDULED. IT WAS NOTED THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT OBSERVED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOTE DISPLAY A RED LIGHT. THE PATIENT PRESENTED TO CLINIC FOR TROUBLESHOOTING AND WHEN CONNECTED TO THE CLINICIAN PROGRAMMER, THE INS DISPLAYED HIGH IMPEDANCE MEASUREMENTS ON ALL FOUR ELECTRODES. DESPITE CHANGING PROGRAMS, MEASUREMENTS REMAINED HIGH SO A REVISION PROCEDURE WAS SCHEDULED. IT WAS NOTED THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT OBSERVED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOTE DISPLAY A RED LIGHT. THE PATIENT PRESENTED TO CLINIC FOR TROUBLESHOOTING AND WHEN CONNECTED TO THE CLINICIAN PROGRAMMER, THE INS DISPLAYED HIGH IMPEDANCE MEASUREMENTS ON ALL FOUR ELECTRODES. DESPITE CHANGING PROGRAMS, MEASUREMENTS REMAINED HIGH SO A REVISION PROCEDURE WAS SCHEDULED. IT WAS NOTED THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION ON (B)(6) 2025 THAT GOT CANCELLED DUE TO THE PATIENT BEING PUT ON PAIN MEDICATION THAT SEEMED TO DECREASE THEIR URINARY SYMPTOMS. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT OBSERVED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOTE DISPLAY A RED LIGHT. THE PATIENT PRESENTED TO CLINIC FOR TROUBLESHOOTING AND WHEN CONNECTED TO THE CLINICIAN PROGRAMMER, THE INS DISPLAYED HIGH IMPEDANCE MEASUREMENTS ON ALL FOUR ELECTRODES. DESPITE CHANGING PROGRAMS, MEASUREMENTS REMAINED HIGH SO A REVISION PROCEDURE WAS SCHEDULED. IT WAS NOTED THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT OBSERVED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOTE DISPLAY A RED LIGHT. THE PATIENT PRESENTED TO CLINIC FOR TROUBLESHOOTING AND WHEN CONNECTED TO THE CLINICIAN PROGRAMMER, THE INS DISPLAYED HIGH IMPEDANCE MEASUREMENTS ON ALL FOUR ELECTRODES. DESPITE CHANGING PROGRAMS, MEASUREMENTS REMAINED HIGH SO A REVISION PROCEDURE WAS SCHEDULED. IT WAS NOTED THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION ON (B)(6) 2025 THAT GOT CANCELLED DUE TO THE PATIENT BEING PUT ON PAIN MEDICATION THAT SEEMED TO DECREASE THEIR URINARY SYMPTOMS. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 530689 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | 10810005340455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Other |