FDA Adverse Event
Malfunction
Summary report: N
SELOX ST 53
MDR report key: 1122175
·
Received August 15, 2008
Report
- Report Number
- 1028232-2008-00923
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 21, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P955037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS LEAD HAD INTERMITTENT OUTPUT. THIS LEAD WAS REPLACED WITH AN ACTIVE FIXATION SETROX S 53.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX ST 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 346366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |