BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2796491 · Received October 18, 2012

    Report

    Report Number
    2796491
    Event Type
    Death
    Date Received
    October 18, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 12, 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

    PT EXPERIENCED RED HEART ALARMS AND NO CAUSE WAS IDENTIFIED DURING DEVICE DIAGNOSTICS TESTING AND EVALUATION; ON (B)(6) 2012. THE PATIENT HAD A MCA ISCHEMIC STROKE WHICH LATER CONVERTED TO A HEMORRHAGIC STROKE. HGBN & LDH 123, 2114 RESPECTIVELY.

    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 Death