FDA Adverse Event
Other
Summary report: N
POLYROX 45 JBP
MDR report key: 736826
·
Received July 17, 2006
Report
- Report Number
- 1028232-2006-00132
- Event Type
- Other
- Date Received
- July 17, 2006
- Date of Event
- January 1, 2006
- Report Date
- July 11, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P750037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
EXPLANTED DUE TO INFECTION. LEADS WERE LASER EXTRACTED. PT HAD PREVIOUS POCKET REVISIONS. ALSO INVOLVED ARE A PHILOS DR ACC, MDR 06-0131 AND POLYROX 53/15, MDR 09-0133. IN 2006, 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 | POLYROX 45 JBP | BRADYCARDIA LEAD | DTB | BIOTRONIK GMBH AND CO. | 120 435 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization |