FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 1944308
·
Received December 6, 2010
Report
- Report Number
- 3007566237-2010-10238
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 24, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE POCKET ADAPTOR PULLED OUT OF THE DEEP BRAIN STIMULATOR HEADER. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| ADAPTER: MODEL 64001, LOT# UNK| ADAPTER: MODEL 64002, LOT# UNK| EXPLANTED:| IMPLANTED: |