FDA Adverse Event
Malfunction
Summary report: N
NUVECTRA CORPORATION
MDR report key: 9695723
·
Received February 11, 2020
Report
- Report Number
- 3010309840-2020-00247
- Event Type
- Malfunction
- Date Received
- February 11, 2020
- Date of Event
- January 14, 2020
- Report Date
- February 11, 2020
- Manufacturer
- NUVECTRA CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P130028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO NUVECTRA THAT THE PATIENT EXPERIENCED COMMUNICATION ISSUES WITH THE STIMULATOR AND EXTERNAL DEVICES. TROUBLESHOOTING WAS PERFORMED WITH NO SUCCESS. THE STIMULATOR WILL BE EXPLANTED ON (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155316 | NUVECTRA CORPORATION | STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) | LGW | NUVECTRA CORPORATION | 2412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |