FDA Adverse Event
Injury
Summary report: N
UNKNOWN SPINAL CORD STIMULATOR
MDR report key: 1953801
·
Received January 4, 2011
Report
- Report Number
- 3007566237-2011-00031
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- January 1, 2010
- Report Date
- December 17, 2010
- Manufacturer
- MEDTORNIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING A CAR ACCIDENT AND WAS ADMITTED TO THE HOSPITAL. THE STIMULATION WAS TURNED OFF AND TESTS WERE DONE TO PROVE THAT ONE OF THE LEADS FELL OFF. SHE ONLY HAD ISSUES WITH HER LEFT LEG, BUT NOW SHE LOST FEELING IN HER RIGHT LEG. FURTHER FOLLOW UP IS NOT POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SPINAL CORD STIMULATOR | LGW | MEDTORNIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |