FDA Adverse Event
Malfunction
Summary report: N
COROX OTW 75-UP STEROID
MDR report key: 1250548
·
Received November 14, 2008
Report
- Report Number
- 1028232-2008-01450
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- June 12, 2007
- Report Date
- October 17, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- NKE
- PMA / PMN Number
- P050023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER STUDY OOS FORM, THIS LEAD WAS "OBSERVED TO BE FRAYED". THIS LEAD WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROX OTW 75-UP STEROID | LV LEAD | NKE | BIOTRONIK GMBH AND CO. | 346542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |