BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3192672 · Received June 25, 2013

    Report

    Report Number
    2916596-2013-00813
    Event Type
    Death
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. 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). THE VAD COORDINATOR REPORTED THAT SUPPORT WAS WITHDRAWN ON THIS PT. HE HAS HAD MULTIPLE ADVERSE EVENTS INCLUDING HEMOLYSIS, LIVER FAILURE AS WELL AS INFECTION. VAD COORDINATOR IS NOT SURE IF THE FAMILY WILL AGREE TO AN AUTOPSY OR IF THEY WILL BE ABLE TO RETURN THE PUMP FOR ANALYSIS. ALSO, NOT SURE IF THEY BELIEVE IT WAS PUMP OR PT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289279 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 126611

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death