BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 3215132 · Received July 10, 2013

    Report

    Report Number
    3215132
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    HEARTWARE, INC.
    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

    INTERMITTENT DRIVELINE FAILURE TO CONTROLLER. DRIVELINE HAD TO BE SUPPORTED AND TIED WITH A STRING TO THE CONTROLLER TO KEEP IT CONNECTED. HEARTWARE CLINICAL CONTACTED AND HEARTWARE ENGINEERS REPAIRED DRIVELINE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317518 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1