BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2834372 · Received November 15, 2012

    Report

    Report Number
    2834372
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 27, 2012
    Report Date
    November 15, 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

    SUBJECT PRESENTED TO EMERGENCY ROOM WITH LVAD ALARMING AND TACHY PALPITATIONS. LVAD STOPPED WHEN SUBJECT CHANGED OVER TO EXTERNAL CONSOLE, WHICH SHE FELT AND HEARD. PROBLEM WAS WITH EXTERNAL POWER LINE WHICH WAS REPLACED.

    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