BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2882465 · Received December 20, 2012

    Report

    Report Number
    2882465
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    January 1, 2012
    Report Date
    December 20, 2012
    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 HAD EF OF LESS THAN 20%, BEGAN HAVING LOW-FLOW ALARMS OF LVAD. CIRCULATORY SUPPORT WAS CALLED TO ER TO EVAL PT, THE CONTROLLERS WERE EXCHANGED BUT THE LVAD CONTINUED TO ALARM. LVAD DEVICE SPEED WAS INCREASED TO 8200 RPM, D/C HOME ON SPEED OF 8000 RPMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1