BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2081297 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00812
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 25, 2010
    Report Date
    February 25, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHIC UNAVAILABLE. PER SOFTWARE INVESTIGATION, THE TRACER TECHNIQUE IS TO BE USED LIGHTLY AROUND FIRM AND BONY AREAS OF THE PATIENT'S NOSE, BROWS. THUS IT WILL NOT BE ACCURATE WHEN TRACING OVER LOOSE SKIN AND HENCE THE RED DOTS. THE USER VERIFIED THE ACCURACY OF THE SYSTEM BY LOCALIZING TO KNOWN ANATOMY TO DETERMINE THE OFFSET AND CHOSE TO ACCEPT THE REGISTRATION. THE SOFTWARE FUNCTIONED EFFECTIVELY IN ALERTING THE USER TO PERFORM THIS ACCURACY VERIFICATION STEP TO MAKE ANY ERROR IN SYSTEM ACCURACY KNOWN TO THE USER.

    Description of Event or Problem · 1

    MEDTRONIC ENT REPRESENTATIVE REPORTED SURGEON IS HAVING DIFFICULTIES REGISTERING A PATIENT WITH THE TRACER TECHNIQUE, DUE TO LOOSE SKIN ON THE PATIENT. THE SURGEON THEN PERFORMED A POINTMERGE REGISTRATION AND FELT SEVERAL MILLIMETERS INACCURATE, BUT COMPLETED THE SURGERY WITH NAVIGATION. NO IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1