FDA Adverse Event
Injury
Summary report: N
NUVECTRA CORPORATION
MDR report key: 8557733
·
Received April 26, 2019
Report
- Report Number
- 3010309840-2019-00197
- Event Type
- Injury
- Date Received
- April 26, 2019
- Date of Event
- March 29, 2019
- Report Date
- April 25, 2019
- Manufacturer
- NUVECTRA CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P130028
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO NUVECTRA THAT DURING IMPLANT OF THE PERMANENT LEADS, THE FIRST LEAD SEPARATED WHILE BEING REMOVED FROM THE PATIENT'S EPIDURAL SPACE TO BE REPOSITIONED. THE SECOND LEAD WAS RE-POSITIONED WITHOUT ISSUE. THE REMAINING PORTION OF THE LEAD WAS LEFT IN THE PATIENT AND THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348822 | NUVECTRA CORPORATION | STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) | LGW | NUVECTRA CORPORATION | 1081-60 | W4138190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |