FDA Adverse Event
Injury
Summary report: N
SETROX S 53
MDR report key: 1221855
·
Received November 3, 2008
Report
- Report Number
- 1028232-2008-01299
- Event Type
- Injury
- Date Received
- November 3, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 30, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER REP. THIS SYSTEM WAS REMOVED DUE TO INFECTION: LUMAX 340 DR-T, MDR 1028232-2008-1297. LINOX SD 65/18, MDR 1028232-2008-01298. SETROX S 53, MDR 1028232-2008-01299.
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 | 73 YR | Hospitalization |