BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2924812 · Received January 17, 2013

    Report

    Report Number
    2916596-2013-00053
    Event Type
    Death
    Date Received
    January 17, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 19, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT CAME INTO THE HOSPITAL APPEARING SEPTIC, MITRAL STENOSIS, AND CULTURES NEGATIVE. PT EXPIRED ON (B)(6) 2012. DEBRIS AT OUTLET STATOR AND OUTFLOW GRAFT NOTED POST MORTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26515 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107489

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death