FDA Adverse Event
Other
Summary report: N
PHILOS II DR
MDR report key: 720184
·
Received May 24, 2006
Report
- Report Number
- 1028232-2006-00061
- Event Type
- Other
- Date Received
- May 24, 2006
- Report Date
- May 15, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DXY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
DEVICE ELECTIVELY EXPLANTED DUE TO INFECTION AND NOT REPLACED. DEVICE RETURNED ON 1/19/2006 WITH OOS REPORT AND COMMENTS: "PEDIATRIC DOCTORS SAW NO NEED FOR PACEMAKER AT THIS TIME. REMOVED DURING HEART SURGERY."
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 | * | Required Intervention |