FDA Adverse Event
Malfunction
Summary report: N
SETROX S 60
MDR report key: 1021851
·
Received March 28, 2008
Report
- Report Number
- 1028232-2008-00351
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- January 7, 2008
- Report Date
- March 7, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER CALL TO REP., THIS SYSTEM WAS REMOVED, DUE TO EROSION AND INFECTION. PHILOS II DR, MDR: 1028232-2008-00350. SETROX S 53, MDR: 1028232-2008-00352.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 60 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 350975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization |