FDA Adverse Event
Injury
Summary report: N
NUVECTRA CORPORATION
MDR report key: 8488822
·
Received April 5, 2019
Report
- Report Number
- 3010309840-2019-00184
- Event Type
- Injury
- Date Received
- April 5, 2019
- Date of Event
- March 8, 2019
- Report Date
- April 4, 2019
- Manufacturer
- NUVECTRA CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P130028
- Adverse Event
- 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 THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT FROM THE FIRST IMPLANT AT THE THORACIC AREA. A SECOND STIMULATOR AND LEADS WERE IMPLANTED AT THE CERVICAL AREA. FOLLOWING THE IMPLANT, THE PATIENT EXPERIENCED RIGHT ARM NUMBNESS. SUBSEQUENTLY, THE LEADS WERE EXPLANTED AND THE PATIENT REGAINED FUNCTIONALITY TO THE RIGHT ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279686 | NUVECTRA CORPORATION | STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) | LGW | NUVECTRA CORPORATION | 1121-75 | W4289034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |