BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2962493 · Received February 14, 2013

    Report

    Report Number
    2962493
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 14, 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

    PT NOTED TO HAVE SOME MYOCARDIAL RECOVERY AND SPEEDS WERE DECREASED ON THE VAD WHICH CONTRIBUTED TO RESOLUTION OF HIS SOB AND OTHER HF SYMPTOMS. HE STOPPED HAVING SUCTION EVENTS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65413 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1