BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2903364 · Received January 4, 2013

    Report

    Report Number
    2916596-2013-00009
    Event Type
    Death
    Date Received
    January 4, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 10, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO PROVIDED TO THE MFR, THE EXPLANTED LVAD WAS NOT EXPLANTED. 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 EXPIRED DUE TO COMPLICATIONS OF A CEREBRAL HEMORRHAGE. THE PT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.9 AT THE TIME OF THE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4025 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 113698

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death