BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2834401 · Received November 15, 2012

    Report

    Report Number
    2834401
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 28, 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

    OCCASIONAL BEEP HEARD. SWITCHED OUT BATTERIES, CLIPS, PM CABLE AND CONTROLLER. ALARMING GOT MORE FREQUENT REQUIRING HOSPITALIZATION. COMPANY TRIED TO REPAIR DRIVELINE BUT PUMP EXCHANGE WAS REQUIRED. DRIVELINE BROKE AT STRAIN RELIEF CLOSE TO PUMP.

    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