FDA Adverse Event
Malfunction
Summary report: N
AXONICS
MDR report key: 14142147
·
Received April 19, 2022
Report
- Report Number
- 3002968685-2022-00032
- Event Type
- Malfunction
- Date Received
- April 19, 2022
- Date of Event
- March 21, 2022
- Report Date
- April 19, 2022
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340141
- PMA / PMN Number
- P180046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE COMPANY WAS MADE AWARE THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO A BROKEN LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2619667 | AXONICS | NEUROSTIMULATOR | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |