BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1062216 · Received June 16, 2008

    Report

    Report Number
    2916596-2008-00073
    Event Type
    Death
    Date Received
    June 16, 2008
    Date of Event
    May 17, 2008
    Report Date
    May 20, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORD THAT THE PT'S FAMILY HAD CALLED HER REPORTING THAT THE PT BEGAN EXPERIENCING LOW FLOW ALARMS AND WAS COMPLAINING OF CHEST PAINS, SWEATING, AND THEN PASSED OUT. EMERGENCY SERVICES WERE CONTACTED AND UPON ARRIVAL, WERE UNSUCCESSFUL IN REVIVING THE PT AND HE EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death