FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1002285
·
Received February 22, 2008
Report
- Report Number
- 3004209178-2008-00896
- Event Type
- Injury
- Date Received
- February 22, 2008
- Report Date
- January 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.,
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT REPORTED THE DEVICE WAS REMOVED DUE TO INFECTION. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THE 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 | YR | Required Intervention | EXPLANTED| IMPLANTED| EXPLANTED| PROGRAMMER MODEL 7438 LOT# NHL003641P| EXPLANTED| LEAD MODEL 3387 LOT# N25027A| IMPLANTED| IMPLANTED| EXTENSION MODEL 7482 LOT# NGK014053N |