BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3880418 · Received April 8, 2014

    Report

    Report Number
    2916596-2014-00549
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    January 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT AFTER APPROXIMATELY 5 MONTHS OF SUPPORT ON THE LVAD, THE PT WAS ROUTINELY TRANSPLANTED. DURING THE MANUFACTURER' INITIAL INVESTIGATION OF THE RETURNED PUMP, A THROMBUS FORMATION WAS FOUND ON ONE OF THE BEARINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211448 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 106015 128679

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention