FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1191181
·
Received September 26, 2008
Report
- Report Number
- 3004209178-2008-06168
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 3, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATOR TURNED OFF ON ITS OWN. THE DEVICE WAS CONFIRMED TO BE ON. HOWEVER, WHEN THE PATIENT WAS AT WORK HIS TREMOR WAS 'BAD.' THE PATIENT WORKED IN A CASINO. USING THE PATIENT PROGRAMMER, THE DEVICE WAS CONFIRMED TO BE TURNED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387| EXPLANTED:| LEAD: MODEL 3387| EXTENSION: MODEL 7482| PROGRAMMER: MODEL PROGRAMMER| IMPLANTED:| IMPLANTED: |