BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3053436 · Received April 11, 2013

    Report

    Report Number
    3053436
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    November 13, 2012
    Report Date
    April 11, 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

    LOW FLOW ALARMS. SPEED CHANGE ECHO SHOWED NORMAL LV UNLOADING WITH REDUCTION IN LV SIZE AND DECREASE IN AV PULSATILITY AT HIGH LEVELS OF SUPPORT CONSISTENT WITH NORMAL LVAD-NATIVE LV RESPONSE. LVAD EXCHANGED. A BREAK WAS NOTED IN DRIVELINE NEAR PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156819 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1