FDA Adverse Event
Injury
Summary report: N
SETROX 5 53
MDR report key: 1201552
·
Received October 16, 2008
Report
- Report Number
- 1028232-2008-01258
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- September 9, 2008
- Report Date
- September 16, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER OOS, THIS LEAD WAS CAPPED DUE TO TOTAL LOSS OF CAPTURE AND TOTAL LOSS OF SENSING. THIS LEAD WAS REPLACED WITH A SELOX JT 45.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX 5 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 350974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization |