BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 1922610 · Received November 19, 2010

    Report

    Report Number
    1723170-2010-00089
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    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

    PATIENT GENDER WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE RETURNED PRODUCT DID NOT MEET SPECIFICATIONS. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. A REPLACEMENT PART WAS SENT TO THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    SITE REPRESENTATIVE REPORTED THAT THEY HAD DIFFICULTY TRACKING INSTRUMENTS DURING NAVIGATION. THE CROSSHAIRS WERE RED. THEY TRIED ADJUSTING THE CAMERA AND REVERIFYING THE SUCTIONS. THE SITE COULD NOT GET IT TO TRACK AND DECIDED TO CANCEL USE OF THE SYSTEM. THERE WAS NO IMPACT TO PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR