FDA Adverse Event
Injury
Summary report: N
NALU NEUROSTIMULATION SYSTEM
MDR report key: 14324151
·
Received May 7, 2022
Report
- Report Number
- 3015425075-2022-00030
- Event Type
- Injury
- Date Received
- May 7, 2022
- Date of Event
- April 1, 2022
- Report Date
- May 6, 2022
- Manufacturer
- NALU MEDICAL INC
- Product Code
- GZF
- UDI-DI
- 00812537033594
- PMA / PMN Number
- K183579
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT REQUESTED DEVICE REMOVAL DUE TO ITCHING AT IMPLANT POCKET SITE. PHYSICIAN ELECTED TO REMOVE THE IPG AND CUT THE LEADS ABOVE THE TINES, LEAVING THE EXCESS LEAD IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1250388 | NALU NEUROSTIMULATION SYSTEM | PERIPHERAL NERVE STIMULATOR | GZF | NALU MEDICAL INC | 71004 / 72006 | 00812537033594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |