FDA Adverse Event
Malfunction
Summary report: N
PHILOS II DR
MDR report key: 1082442
·
Received July 21, 2008
Report
- Report Number
- 1028232-2008-00761
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 23, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DXY
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS RETURNED WITH DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE. THIS DEVICE COULD NOT BE INTERROGATED. THIS DEVICE WAS REPLACED WITH ANOTHER PHILOS II DR. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PATIENT.
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 | 83 YR | Hospitalization |