BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3100588 · Received May 8, 2013

    Report

    Report Number
    3100588
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    May 3, 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

    HEMOLYSIS, INTERMITTENT THEN CONTINUOUS. UPON REMOVAL OF THE DEVICE, THROMBUS WAS NOTED ON THE BEARINGS AND POSSIBLY ROTOR (GROSS VISUALIZATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201471 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1