AXONICS
Report
- Report Number
- 2124215-2026-14253
- Event Type
- Injury
- Date Received
- March 13, 2026
- Date of Event
- February 16, 2026
- Report Date
- April 24, 2026
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340455
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON BLOCK D10: MODEL NUMBER/CATALOG NUMBER: 1201 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: AL1K332332 MODEL/CATALOG DESCRIPTION: TINED LEAD UNIQUE IDENTIFIER (UDI) #: (B)(4). (B)(6). 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 DISCOMFORT AND WEIGHT FLUCTUATIONS 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 ADVERSE EVENT RELATED TO PATIENT CONDITION.
BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON. BLOCK G4: PREMARKET / 510(K) #: ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4).
IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR SURGERY TO REMOVE THEIR NEUROSTIMULATOR AND TINED LEAD. THE PATIENT LOST WEIGHT AND THE IMPLANT BECAME UNCOMFORTABLE, THE PATIENT INITIALLY SAID IT WAS A MENTAL ISSUE. THE PATIENT WAS HESITANT TO HAVE THE EXPLANT SURGERY DUE TO THE COST, BUT THE PHYSICIAN SAID THERE SHOULD BE NO WORRY. THE PATIENT HAD THE EXPLANT AS SCHEDULED. AFTERWARD, THE PHYSICIAN SAID THE EXPLANT SURGERY WENT GREAT, AND THE PATIENT HAD CALMED DOWN FROM THE PREVIOUS DAY.
IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR SURGERY TO REMOVE THEIR NEUROSTIMULATOR AND TINED LEAD. THE PATIENT LOST WEIGHT AND THE IMPLANT BECAME UNCOMFORTABLE, THE PATIENT INITIALLY SAID IT WAS A MENTAL ISSUE. THE PATIENT WAS HESITANT TO HAVE THE EXPLANT SURGERY DUE TO THE COST, BUT THE PHYSICIAN SAID THERE SHOULD BE NO WORRY. THE PATIENT HAD THE EXPLANT AS SCHEDULED. AFTERWARD, THE PHYSICIAN SAID THE EXPLANT SURGERY WENT GREAT, AND THE PATIENT HAD CALMED DOWN FROM THE PREVIOUS DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655975 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | AX1T021541 | 10810005340455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | Hospitalization| R |