FDA Adverse Event
Other
Summary report: N
SELOX ST 53
MDR report key: 731364
·
Received June 29, 2006
Report
- Report Number
- 1028232-2006-00109
- Event Type
- Other
- Date Received
- June 29, 2006
- Report Date
- May 4, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- p950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AN INTERNAL REVIEW REVEALED THAT THIS PRODUCT WAS REMOVED FOR INFECTION AND DISCARDED BY THE HOSPITAL. THIS DEVICE WAS PART OF A SYSTEM REMOVED FOR INFECTION. PLEASE REFERENCE PHILOS II DR-T, SN: 75724421, MDR# 06-0063 FOR ADDITIONAL INFORMATION. A NEW SYSTEM WAS IMPLANTED AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX ST 53 | BRADYCARDIA LEAD | DTB | BIOTRONIK GMBH AND CO. | 346 366 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization |