BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3953601 · Received July 23, 2014

    Report

    Report Number
    1723170-2014-00786
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHIC INFORMATION WAS DECLINED TO BE PROVIDED BY A SITE REPRESENTATIVE INITIALLY REPORTING THE EVENT.THE DECISION TO FILE THIS REPORT WAS DERIVED FROM FINDINGS OF AN INTERNAL MANUFACTURER CAPA ADDRESSING DELAY OF THERAPY TO THE PATIENT.A MEDTRONIC TECHNICAL SERVICES REPRESENTATIVE ASSISTED THE SURGEON ON THE PHONE WITH PROPER REGISTRATION TECHNIQUE OF NOT COLLECTING POINTS BELOW THE EYES. SOFTWARE INVESTIGATION DETERMINED THE SOFTWARE IS FUNCTIONING AS DESIGNED. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, EQUIPMENT TECHNICIAN, REPORTED THAT WHILE IN AN EAR, NOSE & THROAT (ENT) PROCEDURE, THE SURGEON WAS NOT ABLE TO REGISTER THE PATIENT USING THE TRACER REGISTRATION TECHNIQUE. THE EMITTER POSITION WAS ADJUSTED, WITH NO RESOLUTION. THE TRACER PATTERN USED INCLUDED AREAS BELOW THE EYES. IN TROUBLE-SHOOTING IT WAS RECOMMENDED REGISTERING THE PATIENT WITHOUT COLLECTING POINTS BELOW THE EYES AND THIS REGISTRATION PROVED TO BE SUCCESSFUL. THE SURGEON CONFIRMED THE REGISTRATION WAS ACCURATE AND CONTINUED THE SURGERY AS PLANNED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS APPROXIMATELY A 60 MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430343 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1