BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION PLUS

    MDR report key: 1935911 · Received December 3, 2010

    Report

    Report Number
    1723170-2010-00128
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED AT THE SITE AND APPROXIMATELY 30GB OF MEMORY WAS REMOVED. THE SYSTEM AND ALL INSTRUMENTS WERE FULLY FUNCTIONAL. THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A SITE RN REPORTED THAT IN AN ENT CASE, THE SYSTEM FROZE WHILE IN NAVIGATE. THE SITE PERFORMED A TRACER REGISTRATION AND MOVED FORWARD TO NAVIGATE BUT THE SCREEN WAS NOT UPDATING AND THE MOUSE WOULD NOT WORK. THE SURGEON COMPLETED CASE WITH NO IMPACT ON PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR