FDA Adverse Event
Malfunction
Summary report: N
AXONICS
MDR report key: 11864321
·
Received May 21, 2021
Report
- Report Number
- 3002968685-2021-00023
- Event Type
- Malfunction
- Date Received
- May 21, 2021
- Date of Event
- April 26, 2021
- Report Date
- May 21, 2021
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340141
- PMA / PMN Number
- P180046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPANY WAS MADE AWARE ON 04/26/2021 OF A HIGH IMPEDANCE ISSUE. THE PATIENT UNDERWENT A LEAD REVISION SURGERY ON (B)(6) 2021 AND THE ISSUE WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 759371 | AXONICS | NEUROSTIMULATOR | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |