FDA Adverse Event
Injury
Summary report: N
PHILOS II DR
MDR report key: 1080468
·
Received July 21, 2008
Report
- Report Number
- 1028232-2008-00758
- Event Type
- Injury
- Date Received
- July 21, 2008
- Date of Event
- May 9, 2008
- Report Date
- June 18, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DXY
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER BIOTRONIK REPRESENTATIVE, THIS SYSTEM WAS REMOVED DUE TO INFECTION. PER THE OOS, THIS DEVICE WAS REPLACED WITH ANOTHER PHILOS II DR. THE INFECTED SYSTEM: PHILOS II DR, MDR: 1028232-2008-00758; SYNOX SX 45-JBP, MDR: 1028232-2008-00759; SYNOX SX 53-BP, MDR: 1028232-2008-00760.
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 | 88 YR | Hospitalization |