FDA Adverse Event
Malfunction
Summary report: N
SELOX ST 60
MDR report key: 1162258
·
Received September 4, 2008
Report
- Report Number
- 1028232-2008-01072
- Event Type
- Malfunction
- Date Received
- September 4, 2008
- Date of Event
- July 25, 2008
- Report Date
- August 6, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE. PER THE OOS, THIS LEAD HAD NO OUTPUT, TOTAL LOSS OF CAPTURE AND TOTAL LOSS OF SENSING. THIS LEAD HAD A TOTAL LEAD FRACTURE. THIS LEAD WAS REPLACED WITH ANOTHER SELOX ST 60..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX ST 60 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 346367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization |