FDA Adverse Event
Summary report: N
PREMIUM 6500
MDR report key: 3042054
·
Received April 5, 2013
Report
- Report Number
- 3042054
- Date Received
- April 5, 2013
- Date of Event
- March 18, 2013
- Report Date
- April 5, 2013
- Manufacturer
- MEDTRONIC
- Product Code
- LDF
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
THE PHYSICIAN WAS ATTEMPTING TO THREAD THE PACER WIRE AND NEEDLE TO THE HEART WHEN BOTH BROKE FROM THE PHYSICAN'S GRASP AND WERE RETAINED IN THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CAB X 1 AND MITRAL VALVE REPLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141150 | PREMIUM 6500 | ELECTRODE, PACEMAKER, TEMPORARY | LDF | MEDTRONIC | * | AAFO77305F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |