FDA Adverse Event
Malfunction
Summary report: N
THERAPY DUAL 8 ABLATION CATHETER
MDR report key: 703783
·
Received August 16, 2005
Report
- Report Number
- 2030404-2005-00001
- Event Type
- Malfunction
- Date Received
- August 16, 2005
- Report Date
- August 12, 2005
- Manufacturer
- IRVINE BIOMEDICAL, INC. (IBI)
- Product Code
- DRF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
ABLATION ENERGY APPEARS AT THE THIRD ELECTRODE INSTEAD OF THE DISTAL ELECTRODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERAPY DUAL 8 ABLATION CATHETER | EP ABLATION CATHETER | DRF | IRVINE BIOMEDICAL, INC. (IBI) | 83425 | 29467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |