BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3213504 · Received July 3, 2013

    Report

    Report Number
    2916596-2013-00847
    Event Type
    Death
    Date Received
    July 3, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL 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). THE TRANSPLANT COORDINATOR REPORTED THAT THE PT EXPIRED DUE TO MULTI-ORGAN SYSTEM FAILURE. THE PUMP IS RETURNING FOR EVAL DUE TO SUSPECTED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303546 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107482

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death