BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1012529 · Received March 12, 2008

    Report

    Report Number
    2916596-2008-00030
    Event Type
    Death
    Date Received
    March 12, 2008
    Date of Event
    December 20, 2007
    Report Date
    February 11, 2008
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE STUDY COORDINATOR THAT THE PATIENT WAS BROUGHT BACK TO THE OR FOR CHEST CLOSURE, SEVERAL DAYS AFTER THE PUMP WAS IMPLANTED. THE INFLOW VALVE WAS REPORTED TO HAVE DISCONNECTED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 1270

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death