BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2150582 · Received June 22, 2011

    Report

    Report Number
    1723170-2011-01134
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC TECHNICAL SUPPORT TROUBLESHOOTING WITH THE SITE INVOLVING ADJUSTING THE TRACKER AND CAMERA TO BETTER ANGLES RESOLVED THE ISSUE. THE SYSTEM WAS FUNCTIONING AS INTENDED BY NOT ALLOWING THE SITE TO PROCEED WITHOUT PROPER TRACKING.

    Description of Event or Problem · 1

    A SPECIALITY COORDINATOR CALLED IN BECAUSE SHE THOUGHT THAT THEIR SYSTEM WAS FROZEN; THEY COULD NOT ADVANCE IN THE SOFTWARE AND NOTHING WAS WORKING. SHE EXPLAINED IT WAS WORKING FINE AND SUDDENLY STOPPED. MEDTRONIC TECHNICAL SERVICES REPRESENTATIVE CONFIRMED THERE WERE NO ADDITIONAL INSTRUMENTS WITHIN SITE OF THE CAMERA. THE SITE REPRESENTATIVE NOTED THAT THE PATIENT TRACKER WAS FLASHING RED ON THE SCREEN. THE MEDTRONIC REP INSTRUCTED HER TO ADJUST THE TRACKER AND THE CAMERA TO BETTER ANGLES AND THE SYSTEM WAS NO LONGER FROZEN. THE SURGEON WAS ABLE TO PROCEED WITH THE CASE. NO IMPACT ON PATIENT OUTCOME WAS REPORTED.

    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 63 YR