FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN STIMULATOR
MDR report key: 17536757
·
Received August 12, 2023
Report
- Report Number
- MW5143641
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- December 13, 2016
- Manufacturer
- UNKNOWN
- Product Code
- LGW
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED IN AN ARTICLE (LEVINE, A.B., PARRENT, A.G., MACDOUGALL, K.W. STIMULATION OF THE SPINAL CORD AND DORSAL NERVE ROOTS FOR CHRONIC GROIN, PELVIC, AND ABDOMINAL PAIN. PAIN PHYSICIAN. 2016. 19(6):405-412.) THAT ONE FEMALE PATIENT UNDERWENT A TRIAL FOR SPINAL CORD STIMULATION (SCS) AND DORSAL NERVE ROOT STIMULATION (DNRS) FOR MANAGEMENT OF CHRONIC GROIN, PELVIC, OR ABDOMINAL PAIN. THE PATIENT HAD GOOD PAIN REDUCTION WITH THE SCS TRIAL DESPITE SOME UNWANTED STIMULATION IN THE LEGS. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1216903 | UNKNOWN STIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |