FDA Adverse Event
Injury
Summary report: N
NALU NEUROSTIMULATION SYSTEM
MDR report key: 12853700
·
Received November 22, 2021
Report
- Report Number
- 3015425075-2021-00019
- Event Type
- Injury
- Date Received
- November 22, 2021
- Date of Event
- October 27, 2021
- Report Date
- November 17, 2021
- Manufacturer
- NALU MEDICAL INC
- Product Code
- GZF
- UDI-DI
- 00812537033594
- PMA / PMN Number
- K183579
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT'S IPG DEVICE WAS EXPLANTED AFTER PATIENT EXPERIENCED AN INFECTED INCISION SITE. BOTH OF THE LEADS REMAIN IN PATIENT FOR IPG RE-IMPLANT AFTER INFECTION HAS HEALED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1751648 | NALU NEUROSTIMULATION SYSTEM | PERIPHERAL NERVE STIMULATOR | GZF | NALU MEDICAL INC | 71004 | N/A | 00812537033594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |