BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3013660 · Received March 20, 2013

    Report

    Report Number
    3013660
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    May 31, 2012
    Report Date
    March 20, 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

    DELAYED EJECTION OF THE CONTRAST THROUGH THE DEVICE. INADEQUATE FILLING OF THE MACHINE. THIS IS LIKELY DUE TO SOME MEASURE OF INFLOW OBSTRUCTION, EITHER WITH THROMBUS OR WITH FIBRINOUS DEBRIS SOMEWHERE BETWEEN THE ROTOR AND INFLOW CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116395 HEARTMATE II LVAS LVAS DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1