BEUDAMED
    FDA Adverse Event Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3053363 · Received April 11, 2013

    Report

    Report Number
    3053363
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    April 10, 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

    PATIENT ADMITTED FOR SCHEDULED EXPLANT. WHILE SITTING IN BED, PATIENT HAD INTERMITTENT RED HEART ALARMS. BEND RELIEF FOUND TO BE PARTIALLY DISCONNECT ON EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154954 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1