FDA Adverse Event
Injury
Summary report: N
SETROX S 53
MDR report key: 1101424
·
Received August 5, 2008
Report
- Report Number
- 1028232-2008-00842
- Event Type
- Injury
- Date Received
- August 5, 2008
- Date of Event
- March 26, 2008
- Report Date
- July 14, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS SYSTEM WAS REMOVED DUE TO INFECTION. THIS DEVICE WAS REPLACED WITH ANOTHER BIOTRONIK SYSTEM. EXPLANTED SYSTEM: CYLOS DR-T, MDR 1028232-2008-00840; SELOX SR 45, MDR 1028232-2008-00841; SEXTROX S 53, MDR 1028232-2008-00842; SYNOX SX 60/15 BP, MDR 1028232-2008-00843.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO | 350974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization |