FDA Adverse Event
Malfunction
Summary report: N
SELOX SR 45
MDR report key: 1150125
·
Received August 29, 2008
Report
- Report Number
- 1028232-2008-01068
- Event Type
- Malfunction
- Date Received
- August 29, 2008
- Date of Event
- July 24, 2008
- Report Date
- August 4, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER OOS, THIS LEAD WAS REMOVED DUE TO CHRONIC HIGH THRESHOLDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX SR 45 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 343081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization |