FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 1081806
·
Received July 23, 2008
Report
- Report Number
- 1028232-2008-00789
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- May 21, 2008
- Report Date
- June 25, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS, THIS SYSTEM WAS REMOVED DUE TO INFECTION: CYLOS DR-T, MDR 1028232-2008-00788. SETROX S 45, MDR 1028232-2008-00789. SETROX S 53, MDR 1028232-2008-00790.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 45 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |