BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3828915 · Received May 8, 2014

    Report

    Report Number
    2916596-2014-00741
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 10, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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). OUTCOME REPORTED VIA DEVICE TRACKING FORM, CAUSE OF EXPIRATION NOTED AS "STROKE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278189 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE. DSQ THORATEC CORP. 104911 109736

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death