BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3002892 · Received March 13, 2013

    Report

    Report Number
    3002892
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 13, 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 CAME TO CLINIC AND AN INTERROGATION A RED HEART ALARM NOTED AS WELL AS MULTIPLE SPEED DROPS. STATED THAT OVERNIGHT HE HAD A PUMP STOP FOR APPROX 1 MINUTE. PATIENT STABLE AND ADMITTED FOR PLANNED PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105475 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1