BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1853149 · Received September 29, 2010

    Report

    Report Number
    2916596-2010-00249
    Event Type
    Death
    Date Received
    September 29, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 7, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 WAS HAVING HEMOLYSIS ISSUES. THE PT'S CONDITIONS CONTINUED TO WORSEN, AND THE PT DIED APPROX A MONTH LATER OF MULTISYSTEM ORGAN FAILURE RELATED TO THE HEMOLYSIS. THE HOSPITAL RETURNED THE LVAD TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 88424

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death