BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II

    MDR report key: 2938360 · Received December 27, 2012

    Report

    Report Number
    2938360
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    THORATEC, LLC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    OUTFLOW GRAFT HEARTMATE II FAILURE. PATIENT ON LEFT VENTRICULAR ASSIST DEVICE SUPPORT. HE WAS DIAGNOSED WITH AN OUTFLOW GRAFT BEND RELIEF DISCONNECT. HE HAS BEEN REFERRED FOR REVISION OF THE OUTFLOW GRAFT BEND RELIEF.THIS IS RELATED TO A PROBLEM THAT THORATEC HAS ALREADY IDENTIFIED AND PROVIDED A SOLUTION FOR. ALSO, THE FDA IS AWARE OF THIS ISSUE.THIS PARTICULAR SURGERY REPLACED THE OUTFLOW WITH A NEW ONE THAT HAS A SPECIAL COLLAR TO ENSURE PROPER CONNECTION. THIS WAS PROACTIVELY DONE (FOUND ON CXR) THE PATIENT WAS NOT EXPERIENCING ANY PROBLEMS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?GRAFT EXCHANGE.DEVICE #1:IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II VENTRICULAR BYPASS (ASSIST) DEVICE DSQ THORATEC, LLC 103695 112583

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR