BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2933129 · Received January 25, 2013

    Report

    Report Number
    2916596-2013-00083
    Event Type
    Death
    Date Received
    January 25, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS OF A CEREBRAL HEMORRHAGE. THE PATIENT LIVES ALONE AND WAS NOT ANSWERING THE PHONE. THE PATIENT'S NIECE FOUND THE PATIENT DOWN ON FLOOR AT HIS RESIDENCE. IT IS UNKNOWN HOW LONG THE PATIENT HAD BEEN ON THE FLOOR. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT ON ANTI-COAGULATION MEDICATION DUE TO A HISTORY OF GI BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36327 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 85967

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death