FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 2193084
·
Received July 21, 2011
Report
- Report Number
- 3007566237-2011-05647
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Report Date
- June 27, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A (B)(6) STORE SECURITY SYS TURNED THE PT'S NEUROSTIMULATOR ON AND OFF OVER 100 TIMES WHILE THE PT WAS IN THE STORE. THE PT HAD GONE TO (B)(6) SOMETIME WITHIN THE PAST YEAR, AND THE NEUROSTIMULATOR WAS ON AT THE TIME OF EXPOSURE. WHILE THE PT WAS IN THE STORE, THE PT "BANGED INTO PEOPLE" AND WHEN THE NEUROSTIMULATOR WAS TURNED ON AFTER LEAVING THE STORE, THE PT LOST COGNITIVE ABILITIES. THE PT HAD SINCE BEEN IN AND OUT OF REHAB AND HAD BEEN COMBATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | IPG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |