BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2021363 · Received February 8, 2011

    Report

    Report Number
    1723170-2011-00098
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED. SOFTWARE INVESTIGATION RESULTS ARE NOT YET AVAILABLE.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THEY WERE UNABLE TO COMPLETE SUCCESSFUL TRACER REGISTRATION WHILE IN A SYNERGY CRANIAL PROCEDURE. POINT REGISTRATION WAS INACCURATE WITH 2.8 MM PREDICTED ACCURACY, AND THE SURGEON WAS OFF 2-4 MM LATERAL AND POSTERIOR. THE SURGEON CONTINUED THE SURGERY, HOWEVER, DECIDED TO DISCONTINUE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR