BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC HEARTMATE II

    MDR report key: 3955609 · Received July 16, 2014

    Report

    Report Number
    3955609
    Event Type
    Death
    Date Received
    July 16, 2014
    Date of Event
    May 30, 2014
    Report Date
    July 14, 2014
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMS WAS CALLED BY PT'S WIFE. PT WAS FOUND DOWN WITH CONTINUOUS ALARMS FROM LVAD. DISPLAY MODULE READING "NOT CONNECTED". EMS FOUND PT CONNECTED TO POWER MODULE VIA WHITE CABLE BUT NOT BLACK CABLE. DRIVELINE CONNECTED TO CONTROLLER. BLACK CABLE RECONNECTED AND ALARM STOPPED SOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415905 THORATEC HEARTMATE II LVAD DSQ THORATEC CORP VAD 102843

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death