FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1081345
·
Received July 24, 2008
Report
- Report Number
- 3004209178-2008-04330
- Event Type
- Injury
- Date Received
- July 24, 2008
- Date of Event
- December 1, 2007
- Report Date
- June 25, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- MHY
- PMA / PMN Number
- K960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAS BEEN EXPERIENCING MORE "OFF TIME" WHICH HAS BEEN STEADILY INCREASING SINCE EARLY DECEMBER. IT IS UNKNOWN IF IT IS DEVICE RELATED OR THE PROGRESSION OF HIS PARKINSONS DISEASE. IT WAS ALSO REPORTED THE PT HAS BEEN EXPERIENCING SOME FALLING INCIDENCES. NO DATES OR INJURIES WERE REPORTED. SEE MFR REPORT # 3004209178-2008-04431. ADDITIONAL INFO 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 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL 7482| LEAD MODEL 3389| IMPLANTED |