FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1082494
·
Received July 25, 2008
Report
- Report Number
- 3004209178-2008-04413
- Event Type
- Injury
- Date Received
- July 25, 2008
- Report Date
- June 26, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S LEFT FOOT HAS DROPPED SINCE THE PATIENT WAS IMPLANTED WITH THEIR DEEP BRAIN STIMULATOR. THE PATIENT WAS IMPLANTED WITH THE DBS DEVICE TO TREAT PARKINSON'S DISEASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS UNAVAILABLE 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 | IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU129383V| EXPLANTED:| LEAD MODEL 3387 LOT# V010603| IMPLANTED: |