BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2781430 · Received October 10, 2012

    Report

    Report Number
    2781430
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    October 10, 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

    LVAD CHANGE OUT, EVIDENCE OF HEMOLYSIS AND POWER PUMP SURGES. THE BEND RELIEF WAS DISSECTED OUT AND APPEARED AT THIS SITE THERE WAS A PARTIAL DEHISCENCE OF THE BEND RELIEF THAT HAD BEEN PREVIOUSLY DISCUSSED AS A PROBLEM BY THE THORATEC CORPORATION.

    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