FDA Adverse Event
Injury
Summary report: N
AXONICS
MDR report key: 22154476
·
Received June 5, 2025
Report
- Report Number
- 2124215-2025-33828
- Event Type
- Injury
- Date Received
- June 5, 2025
- Date of Event
- May 8, 2025
- Report Date
- June 23, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340455
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL PRODUCT CODE: QON ADDITIONAL PREMARKET/510K: P190006.
Additional Manufacturer Narrative · 0
CORRECTION TO SECTION H6 PATIENT CODES: PAIN CODE UPDATED TO IMPLANT PAIN CODE ADDITIONAL PRODUCT CODE: QON ADDITIONAL PREMARKET/510K: P190006.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING PAIN/DISCOMFORT AT THE BATTERY SITE. X-RAY'S SHOW MIGRATION OF THE LEAD. THE PATIENT UNDERWENT A FULL SYSTEM REVISION SURGERY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING PAIN/DISCOMFORT AT THE BATTERY SITE. X-RAY'S SHOW MIGRATION OF THE LEAD. THE PATIENT UNDERWENT A FULL SYSTEM REVISION SURGERY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1264800 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | AX1T006601 | 10810005340455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention| H | TINED LEAD, 1201, AL1R541615.| TINED LEAD, 1201, AL1R541615. |