BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2749410 · Received September 18, 2012

    Report

    Report Number
    2749410
    Event Type
    Injury
    Date Received
    September 18, 2012
    Date of Event
    July 6, 2012
    Report Date
    September 18, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RED HEART ALARM/CONTINUOUS ALARM, INITIALLY ALERT THEN UNRESPONSIVE. WIFE CHANGED OUT SYSTEM CONTROLLER,REGAINED CONSCIOUSNESS. TO LOCAL ER THEN BWH VAD CLINIC SAME DAY. NEW SYSTEM CONTROLLER NO FURTHER ALARMS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1