BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE LVAS

    MDR report key: 2925681 · Received January 22, 2013

    Report

    Report Number
    2925681
    Event Type
    Death
    Date Received
    January 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 18, 2013
    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

    VAD PARAMETERS ABNORMAL, INITIALLY WITH LOW PI AND NORMAL POWERS. EVENTUALLY, POWERS INCREASED DRAMATICALLY, SUGGESTING THROMBUS. TTE REVEALED NO FLOW THROUGH THE VAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29020 HEARTMATE LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death