AXONICS
Report
- Report Number
- 2124215-2025-58289
- Event Type
- Injury
- Date Received
- August 20, 2025
- Date of Event
- July 23, 2025
- Report Date
- March 5, 2026
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340479
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 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. BASED ON THIS INVESTIGATION, THE INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS CHOSEN AS THE ALLEGATION RELATES TO PAIN WHICH IS ADDRESSED IN THE PRODUCT LABELING AND RISK DOCUMENTATION. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. CORRECTION: BLOCK G2: REPORT SOURCE.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006.
IT WAS REPORTED THE PATIENT REQUESTED TO HAVE THEIR POCKET REVISED DUE TO PAIN. THE PHYSICIAN'S ASSISTANT CALLED THE CLINICAL SPECIALIST (CS) AND ASKED ABOUT CODES FOR THE REVISION PROCEDURE. THE CLINICAL SPECIALIST (CS) DOES NOT KNOW IF THE PATIENT WAS PRESCRIBED MEDICATION. THE PATIENT IS SCHEDULED FOR REVISION SURGERY FOR (B)(6) 2025. REGARDING IF THE PATIENT WAS PRESCRIBED MEDICATION, THE CS WILL TRY TO FIND OUT.
IT WAS REPORTED THE PATIENT REQUESTED TO HAVE THEIR POCKET REVISED DUE TO PAIN. THE PHYSICIAN'S ASSISTANT CALLED THE CLINICAL SPECIALIST (CS) AND ASKED ABOUT CODES FOR THE REVISION PROCEDURE. THE CLINICAL SPECIALIST (CS) DOES NOT KNOW IF THE PATIENT WAS PRESCRIBED MEDICATION. THE PATIENT IS SCHEDULED FOR REVISION SURGERY FOR (B)(6) 2025. REGARDING IF THE PATIENT WAS PRESCRIBED MEDICATION, THE CS WILL TRY TO FIND OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1154667 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 5101 | AX1G190542 | 10810005340479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention |