BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX ELEMENT

    MDR report key: 2081508 · Received April 19, 2011

    Report

    Report Number
    1723170-2011-00879
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THE MEDTRONIC REPRESENTATIVE COULD NOT REPLICATE THE ORIGINAL ISSUE. THE SYSTEM IS WORKING PROPERLY AND IS SUSPECT OF A HARDWARE ISSUE (BENT POST) OR USE ERROR (SPHERES NOT SEATED PROPERLY ON THE POST). FOLLOW-UP INVESTIGATION BY A MEDTRONIC ENT REPRESENTATIVE REPORTS THAT, FOLLOWING THIS CASE, THE SITE HAS BEEN ABLE TO USE THE ENT HEAD TRACKER WITH NO ISSUES. THE SYSTEM IS WORKING PROPERLY.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN AN ENT SURGERY, THE STATUS OF THE INSTRUMENTS WERE FLICKERING BETWEEN GREEN AND RED STATUS. THE SITE REP INFORMED THAT SHE PUT ON NEW OPTICAL MARKERS AND ENSURED THAT THEY WERE FULLY SEATED. A MEDTRONIC REPRESENTATIVE WALKED THROUGH TROUBLESHOOTING WITH THE SITE REP TO THE POINT WHERE THE STATUS OF THE FRAME STAYED GREEN WITH A GEOMETRY ERROR BELOW 0.10. NEXT REMOVED THE OPTICAL MARKER AND INFORMED HER THAT THE POST WAS BENT. THEN THE SITE STARTED EXPERIENCING A SIMILAR PROBLEM WITH THE PASSIVE PLANNER BLUNT. AT THIS POINT, THE SURGEON DID NOT WANT TO TROUBLESHOOT ANYMORE AND CONTINUED THE SURGERY WITHOUT THE USE OF THE LANDMARX ELEMENT. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR