BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2092840 · Received May 5, 2011

    Report

    Report Number
    1723170-2011-00934
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER AND PT WEIGHT WERE UNAVAILABLE FROM THE SITE. THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYSTEM WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A RN REPORTED THAT SHE WAS PULLED INTO A CASE AFTER THE SURGEON ELECTED TO STOP USING LANDMARK ELEMENT FOR NAVIGATION. SHE WAS TOLD BY THE STAFF THAT "IT FROZE" AND THAT THE SURGEON "WENT BACK TO RE-REGISTER THE PT AND WAS UNABLE TO REGISTER THE PT." THE RN WAS ABLE TO MOVE THROUGH SCREENS IN THE SOFTWARE, INSTRUMENT TRACKING DETAILS WERE ALL GREEN, NO INSTRUMENTS DISPLAYED RED STATUS. SHE SAID THE SURGEON ELECTED TO CONTINUE THE SURGERY WITHOUT TRYING TO RE-REGISTER THE PT. 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 65 YR