BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2800381 · Received October 18, 2012

    Report

    Report Number
    2916596-2012-01010
    Event Type
    Death
    Date Received
    October 18, 2012
    Date of Event
    August 16, 2012
    Report Date
    September 21, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO PROVIDED TO THE MFR, THE EXPLANTED LVAD WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR¿S INVESTIGATION 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 FAILED TO PROGRESS POST IMPLANTATION OF THE LVAD AND WAS UNABLE TO BE WEANED OFF THE VENTILATOR. THE PT WAS PLACED ON SUPPORTIVE CARE FOR A FEW MONTHS AND SUPPORT WAS SUBSEQUENTLY WITHDRAWN PER THE FAMILY¿S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 113239

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death