FDA Adverse Event
Malfunction
Summary report: N
NUVECTRA CORPORATION
MDR report key: 8701595
·
Received June 14, 2019
Report
- Report Number
- 3010309840-2019-00211
- Event Type
- Malfunction
- Date Received
- June 14, 2019
- Date of Event
- May 10, 2019
- Report Date
- June 7, 2019
- Manufacturer
- NUVECTRA CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P130028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO NUVECTRA THAT A REVISION WAS PERFORMED TO PROVIDE ADDITIONAL COVERAGE. DURING THE SURGERY, THE PERCUTANEOUS LEAD WAS REMOVED AND REPLACED WITH A PADDLE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495542 | NUVECTRA CORPORATION | STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) | LGW | NUVECTRA CORPORATION | 1124-60 | W4313521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |