BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3003853 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00259
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 PERFUSIONIST REPORTED THAT THE PT PASSED AWAY AFTER APPROX 9 MONTHS OF SUPPORT ON THE LVAD. THE PT'S CAUSE OF DEATH WAS NOT REPORTED TO THE MFR; HOWEVER, THE HOSPITAL REQUESTED AN EXAMINATION THE EXPLANTED PUMP FOR "THROMBUS/INFECTION AND DEFECTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103480 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 111848

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death