BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3203441 · Received July 2, 2013

    Report

    Report Number
    3203441
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 2, 2012
    Report Date
    June 21, 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 CALLED COORDINATOR C/O INTERMITTENT ALARMS WHEN BENDING, WHICH BECAME MORE FREQUENT WITH ANY MOVEMENT. PT. SEEN IN CLINIC DEVICE INTERROGATED AND WAVEFORMS SENT TO THORATEC. THEY DIAGNOSED A PROBABLE BROKEN WIRE. EXPLANT DONE AND PUMP DL REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302634 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1