FDA Adverse Event
Injury
Summary report: N
SETROX S 53
MDR report key: 1060915
·
Received June 13, 2008
Report
- Report Number
- 1028232-2008-00644
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- April 28, 2008
- Report Date
- May 21, 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
PER OOS, THIS SYSTEM WAS REMOVED DUE TO INFECTION. ON 6/2/2008 THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM HEART CARE MEDICAL. SYSTEM INFO: LINOX SD 65/16, MDR 1028232-2008-00645. LUMAX 340 DR-T, MDR 1028232-2008-00643. SETROX S 53, MDR 1028232-2008-00644.
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 | 69 YR | Hospitalization |