FDA Adverse Event
Malfunction
Summary report: N
NUVECTRA CORPORATION
MDR report key: 8620173
·
Received May 17, 2019
Report
- Report Number
- 3010309840-2019-00206
- Event Type
- Malfunction
- Date Received
- May 17, 2019
- Date of Event
- April 18, 2019
- Report Date
- May 17, 2019
- Manufacturer
- NUVECTRA CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P130028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO NUVECTRA THAT THE PATIENT COULD NOT FEEL ANY PARESTHESIA FROM THE RIGHT LEAD. PATIENT ONLY FELT PAIN OR SHARPNESS WHEN PROGRAMMED AND TURNED ON. TROUBLESHOOTING WAS PERFORMED AND REVEALED A DAMAGED LEAD AND IMPEDANCE ISSUES. SUBSEQUENTLY, THE LEAD WAS REPLACED DURING THE REVISION SURGERY AND THE PATIENT IS RECEIVING COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 415340 | NUVECTRA CORPORATION | STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) | LGW | NUVECTRA CORPORATION | 1124-60 | W4056385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |