FDA Adverse Event
Injury
Summary report: N
COROX OTW 75-UP STEROID
MDR report key: 1231648
·
Received November 14, 2008
Report
- Report Number
- 1028232-2008-01475
- Event Type
- Injury
- Date Received
- November 14, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- MRM
- PMA / PMN Number
- P050023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER STUDY ADVERSE EVENT FORM, THIS LEAD CAUSED PHRENIC NERVE STIMULATION. THIS LEAD WAS ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROX OTW 75-UP STEROID | LV LEAD | MRM | BIOTRONIK GMBH AND CO | 346542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization |