BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3100593 · Received May 8, 2013

    Report

    Report Number
    3100593
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 23, 2013
    Report Date
    May 1, 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

    POWER AND FLOW ELEVATION W/ INTERMITTENT NORMALIZATION OF PARAMETERS. ECHO SHOWED LVEDD OF 7.3 FROM 6.6-6.8 USUALLY AND INTERMITTENT OPENING OF AORTIC VALVE. THE INFLOW CANNULA SITTING CLOSE TO THE SEPTUM, BUT NO EVIDENT TURBULENCE, SUCTION OR OBSTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201875 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1