FDA Adverse Event
Injury
Summary report: N
NALU NEUROSTIMULATION SYSTEM
MDR report key: 14112442
·
Received April 14, 2022
Report
- Report Number
- 3015425075-2022-00023
- Event Type
- Injury
- Date Received
- April 14, 2022
- Date of Event
- March 15, 2022
- Report Date
- April 13, 2022
- Manufacturer
- NALU MEDICAL INC
- Product Code
- GZF
- UDI-DI
- 00812537036182
- PMA / PMN Number
- K183579
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT UNDERWENT ELECTIVE REVISION SURGERY TO RELOCATE THE IPG. THE IPG WAS DAMAGED IN THE PROCESS AND HAD TO BE REPLACED WITH A NEW ONE DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1278962 | NALU NEUROSTIMULATION SYSTEM | PERIPHERAL NERVE STIMULATOR | GZF | NALU MEDICAL INC | 71020 | 00812537036182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |