AXONICS
Report
- Report Number
- 2124215-2025-47320
- Event Type
- Injury
- Date Received
- July 15, 2025
- Date of Event
- June 17, 2025
- Report Date
- February 16, 2026
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340066
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.
IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING PAIN IN THE VAGINAL AREA FOR APPROXIMATELY THREE WEEKS, WHICH WAS SAID TO IMPROVE WHEN THE INS WAS TURNED OFF. THE PATIENT HAS BEEN TAKING AZO FOR THE PRESSURE, WHICH REPORTEDLY PROVIDES RELIEF. NO FOLLOW-UP OR REMOVAL APPOINTMENT HAS BEEN SCHEDULED YET, BUT THE PATIENT EXPRESSED A DESIRE TO HAVE THE INS REMOVED. THE CAUSE OF THE PAIN IS UNKNOWN, AND NO DEVICE MALFUNCTION HAS BEEN CONFIRMED AT THIS TIME. THE PATIENT STATES THAT THEY ARE TAKING AZO TO MANAGE THEIR PAIN. THEY ARE UNSURE OF THE EXACT DAY WHEN THE PAIN FIRST STARTED. THE PATIENT REPORTS THAT THE PAIN DISAPPEARS AFTER THE INS IS TURNED OFF, BUT THEY CONTINUE TO TAKE AZO IF THEY EXPERIENCE ANY PAIN. ADDITIONALLY, THE PATIENT HAS NOT YET FOLLOWED UP WITH THEIR PHYSICIAN.
IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING PAIN IN THE VAGINAL AREA FOR APPROXIMATELY THREE WEEKS, WHICH WAS SAID TO IMPROVE WHEN THE INS WAS TURNED OFF. THE PATIENT HAS BEEN TAKING AZO FOR THE PRESSURE, WHICH REPORTEDLY PROVIDES RELIEF. NO FOLLOW-UP OR REMOVAL APPOINTMENT HAS BEEN SCHEDULED YET, BUT THE PATIENT EXPRESSED A DESIRE TO HAVE THE INS REMOVED. THE CAUSE OF THE PAIN IS UNKNOWN, AND NO DEVICE MALFUNCTION HAS BEEN CONFIRMED AT THIS TIME. THE PATIENT STATES THAT THEY ARE TAKING AZO TO MANAGE THEIR PAIN. THEY ARE UNSURE OF THE EXACT DAY WHEN THE PAIN FIRST STARTED. THE PATIENT REPORTS THAT THE PAIN DISAPPEARS AFTER THE INS IS TURNED OFF, BUT THEY CONTINUE TO TAKE AZO IF THEY EXPERIENCE ANY PAIN. ADDITIONALLY, THE PATIENT HAS NOT YET FOLLOWED UP WITH THEIR PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138178 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1101 | AX1G166846 | 10810005340066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention |