BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRICULAR ASIST DEVICE (IVAD)

    MDR report key: 881872 · Received July 19, 2007

    Report

    Report Number
    2916596-2007-00108
    Event Type
    Death
    Date Received
    July 19, 2007
    Date of Event
    June 18, 2007
    Report Date
    June 18, 2007
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS COOKING WHILE AT HOME AND HAD TOLD HER SISTER-IN-LAW THAT SHE WAS GOING TO THE BATHROOM AND WOULD BE RIGHT BACK. THE PATIENT WAS FOUND WITH THE IVAD PERCUTANEOUS LEAD SEPARATED AT THE PUMP CONNECTION AND THE PUMP HAD STOPPED. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL, THEY ATTEMPTED TO HAND PUMP THE PATIENT; HOWEVER, THEY WERE NOT SUCCESSFUL IN DOING SO DUE TO A WIRE REPORTEDLY BEING IN THE WAY. THE PT WAS THEN TRANSPORTED TO THE HOSPITAL AND AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR ASIST DEVICE (IVAD) IMPLANTABLE VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 10012-0000-001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death