BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3852996 · Received May 23, 2014

    Report

    Report Number
    2916596-2014-00710
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. 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 2 WEEKS POST-IMPLANT, IT WAS REPORTED THAT THE PT EXPIRED AND THE REPORTED CAUSE OF DEATH WAS MULTI ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309108 HEARTMATE II LVAS, EUROPE DSQ; LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 134287

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death