BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2092171 · Received April 27, 2011

    Report

    Report Number
    1723170-2011-00915
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND FOUND THAT THE USER WAS PLACING THE EMITTER TOO FAR AWAY FROM THE PATIENT TO TRACK THE INSTRUMENTS. HE TRAINED THE USER ON CORRECT PLACEMENT OF THE EMITTER AND THEY HAVE SINCE USED THE SYSTEM IN SUCCESSFUL CASES. NO FURTHER ISSUES AFTER USER TRAINING.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED INTERMITTENT TRACKING WHILE IN AN ENT PROCEDURE. THE SITE REP REPORTED THE SURGEON WAS ABLE TO COMPLETE A SUCCESSFUL TRACER REGISTRATION, BUT THE TRACKING OF THE REGISTRATION PROBE WAS INTERMITTENT ON THE RIGHT SIDE OF THE FACE. THE SITE REP REPORTED THAT THERE WAS NO METAL IN THE FIELD. A MEDTRONIC REPRESENTATIVE WALKED THE SITE REP THROUGH PROPER PLACEMENT OF THE EMITTER AND INFORMED HER OF HOW TO CHECK TRACKING DETAILS TO ENSURE THAT THE INSTRUMENTS WERE BEING TRACKED CORRECTLY. THE SURGERY WAS COMPLETED WITH THE USE OF THE FUSION 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 INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR