BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3062087 · Received April 16, 2013

    Report

    Report Number
    3062087
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    October 6, 2012
    Report Date
    April 8, 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

    ON (B)(6), AV WAS OPENING REGARDLESS OF VAD SPEED. ON (B)(6), CARDIAC CT SHOWED TOTAL THROMBOSIS OF LVAD OUTFLOW CANNULA. VAD EXCHANGED (B)(6). THROMBUS NOTED IN INFLOW CANNULA AND OUTFLOW GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163619 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1