FDA Adverse Event
Injury
Summary report: N
SELOX SR 45
MDR report key: 1101264
·
Received August 5, 2008
Report
- Report Number
- 1028232-2008-00822
- Event Type
- Injury
- Date Received
- August 5, 2008
- Date of Event
- June 19, 2008
- Report Date
- July 3, 2008
- Manufacturer
- BIOTRONIK, GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER THE OOS, THIS SYSTEM WAS REMOVED DUE TO AN INFECTION THAT WAS NOT RELATED TO THE IMPLANT, PER DR. THIS LEAD WAS REPLACED WITH A SETROX S 45, IN 2008. THE EXPLANTED SYSTEM: PHILOS II DR, MDR: 1028232-2008-00821; SELOX SR 45, MDR: 1028232-2008-00822. AROX 53-BP, MDR: 1028232-2008-00823.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX SR 45 | PACER LEAD | DTB | BIOTRONIK, GMBH AND CO. | 343081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization |