FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1203513
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06634
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WOULD TURN OFF WHEN THE PATIENT USED HIS TELEVISION REMOTE CONTROL. THE PATIENT DID NOT HAVE A PROGRAMMER TO TURN THE DEVICE BACK ON. NO PATIENT SYMPTOMS WERE REPORTED. 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 | 68 YR | LEAD: MODEL 3387| LEAD: MODEL 3387| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482 |