AXONICS
Report
- Report Number
- 2124215-2025-64639
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Date of Event
- July 31, 2025
- Report Date
- November 18, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340455
- PMA / PMN Number
- P180046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. THIS REPORT IS BEING FILED FOR A CORRECTION TO FIELD H6. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. A DEVICE WAS NOT RETURNED, AND PICTURES WERE NOT PROVIDED, RESULTING IN AN INABILITY TO ANALYZE THE DEVICE AND IDENTIFY IF A MALFUNCTION OCCURRED. BASED ON THE INFORMATION AVAILABLE, THE PATIENT WAS IDENTIFIED IMPLANTED WITH AN EXPIRED NEUROSTIMULATOR IMPLANT POST-IMPLANTATION. IFU WAS REVIEWED AND STATES "DO NOT IMPLANT THE COMPONENT IF ANY OF THE FOLLOWING HAVE OCCURRED: THE USE-BY DATE HAS EXPIRED". BASED ON REVIEW OF COMPLAINT AND IFU, IT IS MOST PROBABLE THAT "FAILURE TO FOLLOW INSTRUCTIONS" CAUSE EVENT AS DEVICE WAS IMPLANTED AFTER EXPIRATION DATE. THEREFORE, THE INVESTIGATION CONCLUSION CODE OF "FAILURE TO FOLLOW INSTRUCTIONS" WAS CHOSEN. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.
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 THE PATIENT WAS IMPLANTED ON (B)(6) 2025 AND THE SURGERY CENTER NOTIFIED THE PATIENT'S LOCAL REPRESENTATIVES THAT THE NEUROSTIMULATOR IMPLANT WAS EXPIRED. THE FACILITY WAS GOING THROUGH THEIR IMPLANT NOTES AND THAT WAS HOW THEY FOUND OUT THE DEVICE IS EXPIRED. THEY HAVE NOT MADE THE PHYSICIAN AWARE YET AS THEY WANT TO UNDERSTAND THE COURSE OF ACTION FIRST. PRODUCT MANAGEMENT SAID FROM A DEVICE LABELING AND PRODUCT EXPIRATION STANDPOINT, THE USE-BY-DATE REFLECTS STERILIZATION RISK PER THE FDA APPROVAL. FROM A DEVICE FUNCTION STANDPOINT, THE EXPIRATION DATE DOES NOT RELATE TO THE FUNCTIONALITY OF THE PRODUCT. SO, THE RISK WHEN IMPLANTING AN EXPIRED PRODUCT HAS TO DO WITH STERILITY AND INFECTION RISK. THE PROTOCOL FOR THIS IS TO RECORD THE EVENT BY WAY OF COMPLAINT, WHICH SHOULD HAVE BEEN DONE ALREADY BUT IF NOT NEEDS TO BE DONE IMMEDIATELY. THE NORMAL COMPLAINT HANDLING PROCESS WILL PICK UP FROM THERE AS PER USUAL. TO THE CENTER'S QUESTION ON GUIDANCE AS MENTIONED- NO ADDED RISK TO PRODUCT FUNCTION RELATED TO EXPIRATION. GIVEN THAT THE RISK RELATED TO EXPIRED PRODUCT IS INFECTION, THE CENTER SHOULD MONITOR THE PATIENT FOR SIGNS OF POCKET INFECTION. NO ADDED GUIDANCE OR STEPS NEEDED; HOWEVER, THEY SHOULD FOLLOW ANY ADDITIONAL STEPS THEY MAY HAVE WITH THEIR PROCESSES.
IT WAS REPORTED THE PATIENT WAS IMPLANTED ON (B)(6) 2025 AND THE SURGERY CENTER NOTIFIED THE PATIENT'S LOCAL REPRESENTATIVES THAT THE NEUROSTIMULATOR IMPLANT WAS EXPIRED. THE FACILITY WAS GOING THROUGH THEIR IMPLANT NOTES AND THAT WAS HOW THEY FOUND OUT THE DEVICE IS EXPIRED. THE SURGERY CENTER WAS ADVISED THAT IMPLANT PAST EXPIRATION DID NOT POSE A RISK TO PRODUCT FUNCTION BUT TO MONITOR SHOULD THE PATIENT EXHIBIT ANY SIGNS INDICATING LOSS OF STERILITY DUE TO EXCEEDING SHELF LIFE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THE PATIENT WAS IMPLANTED ON (B)(6) 2025 AND THE SURGERY CENTER NOTIFIED THE PATIENT'S LOCAL REPRESENTATIVES THAT THE NEUROSTIMULATOR IMPLANT WAS EXPIRED. THE FACILITY WAS GOING THROUGH THEIR IMPLANT NOTES AND THAT WAS HOW THEY FOUND OUT THE DEVICE IS EXPIRED. THEY HAVE NOT MADE THE PHYSICIAN AWARE YET AS THEY WANT TO UNDERSTAND THE COURSE OF ACTION FIRST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1974975 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | AX1T057023 | 10810005340455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male |