BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3090615 · Received May 2, 2013

    Report

    Report Number
    3090615
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 28, 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

    LVAD RPMS WERE DECREASED AND THE LVAD UNEXPECTEDLY SHUT OFF. IT WAS SUCCESSFULLY TURNED BACK ON. IT WAS FELT THAT THE PATIENT LIKELY HAS A FRACTURED DRIVELINE/WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192834 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1