FDA Adverse Event
Malfunction
Summary report: N
SETROX S 53
MDR report key: 1243027
·
Received November 20, 2008
Report
- Report Number
- 1028232-2008-01491
- Event Type
- Malfunction
- Date Received
- November 20, 2008
- Date of Event
- October 17, 2008
- Report Date
- October 23, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER OOS, THIS LEAD HAD INTERMITTENT OUTPUT. THIS LEAD WAS REPLACED WITH A COMPETITOR'S LEAD.
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 | UNK | Hospitalization |