BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2040340 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00657
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SITE REC'D ADD'L TRAINING ON EMITTER PLACEMENT AND AXIEM PROCEDURES. SOFTWARE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A SITE REP REPORTED A PROBLEM TRACKING DURING AN ENT SURGICAL PROCEDURE. SHE COMMUNICATED THAT THE SURGEON WAS ABLE TO SUCCESSFULLY REGISTER THE PT VIA TRACER REGISTRATION. IN NAVIGATION SHE SAID THE SURGEON REPORTED INTERMITTENT TRACKING. A MEDTRONIC REP WALKED THROUGH TROUBLESHOOTING WITH THE SITE REP AND EXPLAINED THE IMPORTANCE OF AXIEM PLACEMENT. PHYSICIAN EVENTUALLY ELECTED TO CONTINUE W/O USING THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PT 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