BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042058 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00377
    Event Type
    Death
    Date Received
    April 4, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT DIED FROM NATURAL CAUSES, AND PUMP SUPPORT WAS WITHDRAWN. IT WAS ALSO REPORTED THAT THE PT'S DEATH WAS NOT RELATED TO A DEVICE MALFUNCTION OR VAD THERAPY. ADDITIONAL INFO WAS RECEIVED FROM THE PHYSICIAN THAT THE PUMP WAS WORKING FINE AT THE TIME OF THE PT'S DEATH AND WAS NOT RELATED TO THE PT'S ISSUES. THE PT HAD RIGHT-SIDED HEART FAILURE, MULTIPLE GI BLEEDING EPISODES, AS WELL AS RENAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137736 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 97530

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death