FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 1556108
·
Received December 4, 2009
Report
- Report Number
- 1028232-2009-01605
- Event Type
- Injury
- Date Received
- December 4, 2009
- Date of Event
- September 18, 2009
- Report Date
- November 5, 2009
- Manufacturer
- BIOTRONIK SE & CO KG
- 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 HEMATOMA AND WAS LATER REPLACED WITH ANOTHER BIOTRONIK SYSTEM. CYLOS DR, MDR 1028232-2009-01604. SETROX S 53, MDR 1023282-2009-01606.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 45 | PACER LEAD | DTB | BIOTRONIK SE & CO KG | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization |