BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1664833 · Received April 20, 2010

    Report

    Report Number
    2916596-2010-00093
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 25, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPIRED WHILE IN THE HOSPITAL. THE PT WAS REPORTED TO HAVE BEEN HEMOLYSING, THROWING CLOTS AND TOWARDS THE END OF LIFE, WAS EXPERIENCING POWER SURGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 87029

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death