FDA Adverse Event
Other
Summary report: N
PHILOS DR ACC
MDR report key: 736846
·
Received July 17, 2006
Report
- Report Number
- 1028232-2006-00131
- Event Type
- Other
- Date Received
- July 17, 2006
- Date of Event
- January 1, 2006
- Report Date
- July 10, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- DXY
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
LEADS WERE EXPLANTED IN 2006, DUE TO INFECTION. LEADS WERE LASER EXTRACTED. THE PT HAD HAD TWO PREVIOUS POCKET REVISION PROCEDURES. LEADS INVOLVED: POLYROX 45 JBP, MDR 06-0132 AND POLYROX 53/13 BP, MDR 06-0133. SIX DAYS LATER, REP REPORTED THAT THE INFECTION CLEARED AND THE PT WAS IMPLANTED WITH A NEW SYSTEM TODAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILOS DR ACC | PACEMAKER | DXY | BIOTRONIK GMBH AND CO | 337 157 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization |