FDA Adverse Event
Injury
Summary report: N
PHILOS II DR
MDR report key: 1020489
·
Received March 28, 2008
Report
- Report Number
- 1028232-2008-00376
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- January 22, 2008
- Report Date
- March 10, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DXY
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION. IT WILL NOT BE RETURNED TO BINC. ALSO REMOVED: SETROX S 53, MDR: 1028232-2008-00377. SETROX S 45, MDR: 1028232-2008-00376.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILOS II DR | PACEMAKER | DXY | BIOTRONIK GMBH AND CO. | 341826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |