FDA Adverse Event
Injury
Summary report: N
PHILOS II DR
MDR report key: 1001003
·
Received February 20, 2008
Report
- Report Number
- 1028232-2008-00112
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- December 10, 2007
- Report Date
- January 28, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- DXY
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER THE OOS, THIS DEVICE WAS REMOVED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILOS II DR | P950037 | DXY | BIOTRONIK GMBH AND CO | 341826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |