BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2792401 · Received October 10, 2012

    Report

    Report Number
    2916596-2012-00963
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    September 8, 2012
    Report Date
    September 11, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 VAD COORDINATOR REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL WITH SEPTIC SHOCK SECONDARY TO A BACTERIAL INFECTION OF THE COLON (C DIFF COLITIS) AND SUPPORT WAS SUBSEQUENTLY WITHDRAWN. ACCORDING TO THE INFO RECEIVED, THE LVAD WAS TURNED OFF APPROX THREE HOURS BEFORE THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109874

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death