BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3852951 · Received May 23, 2014

    Report

    Report Number
    2916596-2014-00821
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    November 26, 2013
    Report Date
    April 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROX 4 DAYS OF VAD SUPPORT, IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPIRED FROM "SEPSIS AND MULTI ORGAN FAILURE." NO FURTHER INFO WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307769 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 131099

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death