FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC, INC
MDR report key: 1026942
·
Received April 8, 2008
Report
- Report Number
- MW5006158
- Event Type
- Malfunction
- Date Received
- April 8, 2008
- Date of Event
- March 21, 2008
- Report Date
- March 26, 2008
- Manufacturer
- MEDTRONIC, INC
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MARKER BEAD FROM 6 FRENCH MEDTRONIC EXPORT CATHETER DISLODGED FROM CATHETER. REMAINS IN LAD ARTERY. USED BY CARDIOLOGIST
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC, INC | 6 FR EXPORT CATHETER | DQO | MEDTRONIC, INC | EXPORTXT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |