AXONICS
Report
- Report Number
- 2124215-2025-67386
- Event Type
- Malfunction
- Date Received
- October 1, 2025
- Date of Event
- September 4, 2025
- Report Date
- April 14, 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
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON. BLOCK G4: PREMARKET / 510(K) #: ADDITIONAL PREMARKET / 510(K) # P190006. BLOCK H11: INVESTIGATION DETAILS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE; HOWEVER, THE PRODUCT WAS NOT RETURNED. IT WAS CONFIRMED THE DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF PACKAGING, FOREIGN MATTER WAS DEFINED IN THE PRODUCT RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006.
IT WAS REPORTED, DURING A STAGE 1 PROCEDURE, THE CIRCULATING NURSE OPENED THE TINED LEAD KIT AND FOUND A HAIR. AT THE TIME, THE SCRUB HAD ALREADY PLACED THE TINED LEAD ON THE TABLE; THEREFORE, BELIEVING THERE WAS CROSS CONTAMINATION. THEY ENDED UP SCRAPPING THE ENTIRE BACK TABLE, INCLUDING THE LEAD IMPLANT KIT AND PNE KIT. THE PRODUCTS WERE REPLACED FROM THE TRUNK STOCK. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED, DURING A STAGE 1 PROCEDURE, THE CIRCULATING NURSE OPENED THE TINED LEAD KIT AND FOUND A HAIR. AT THE TIME, THE SCRUB HAD ALREADY PLACED THE TINED LEAD ON THE TABLE; THEREFORE, BELIEVING THERE WAS CROSS CONTAMINATION. THEY ENDED UP SCRAPPING THE ENTIRE BACK TABLE, INCLUDING THE LEAD IMPLANT KIT AND PNE KIT. THE PRODUCTS WERE REPLACED FROM THE TRUNK STOCK. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2459010 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | AL10002078 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |