FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 1073652
·
Received July 8, 2008
Report
- Report Number
- 1028232-2008-00794
- Event Type
- Injury
- Date Received
- July 8, 2008
- Date of Event
- February 25, 2008
- Report Date
- June 6, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER THE OOS, THIS LEAD BECAME DISLODGED AND COULD NOT BE REPOSITIONED. IT WAS REPLACED WITH A SETROX JT 45. THIS LEAD WAS NOT RETURNED.
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 | 82 YR | Hospitalization |