BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2061547 · Received March 16, 2011

    Report

    Report Number
    1723170-2011-00663
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM AND INSTRUMENTS WERE EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYSTEM AND INSTRUMENTS WERE FULLY FUNCTIONAL. PER DISCUSSION BETWEEN THE MEDTRONIC REPRESENTATIVE AND SITE STAFF ISSUE WAS BELIEVED TO BE CAUSED BY POOR REGISTRATION TECHNIQUE SINCE SUBSEQUENT USES OF THE SYSTEM SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN AN ENT CASE, THE SURGEON FELT INACCURATE USING THE LANDMARX EVOLUTION SYSTEM. THE SITE REPRESENTATIVE COULD NOT PROVIDE ANY MORE DETAILS OTHER THAN THE SURGEON FELT SEVERAL MM INACCURATE. THE SURGEON CONTINUED THE SURGERY WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.

    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 18 YR