FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1193451
·
Received October 7, 2008
Report
- Report Number
- 3004209178-2008-06398
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Report Date
- September 12, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED PRESSURE IN HIS HEAD AND CHEST WITH A TINGLING SENSATION, AFTER COMING OUT OF A STORE AND TURNING ON THE CAR. AFTER RETURNING HOME THE PATIENT "JUST DIDN'T FEEL RIGHT" AND IT WAS THOUGHT THAT SOMETHING HAD CHANGED WITH THE DBS SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
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 | Required Intervention | EXTENSION: MODEL 7482| EXPLANTED| EXPLANTED| EXTENSION: MODEL 7482| LEAD: MODEL 3389| EXPLANTED |