BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2160119 · Received May 13, 2011

    Report

    Report Number
    1723170-2011-00967
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. PART NOT YET RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC (B)(4) REP REPORTED THAT THE GEOMETRY ERROR OF THE REGISTRATION PROBE WENT TO APPROX .5 WHILE IN AN ENT PROCEDURE. THE PROBE WAS GOING FROM GREEN TO RED STATUS. THERE WAS A CLEAR LINE OF SITE, HOWEVER, TROUBLE-SHOOTING DID NOT RESOLVE THE ISSUE. PULLING THE SYSTEM CLOSER, FROM 6.5 FEET TO ABOUT 4 FEET, CREATED SOME IMPROVEMENT. LATER IN THE CASE, THE CRANIAL REFERENCE FRAME STARTED TO EXPERIENCED THE SAME ISSUE. THE SYSTEM WAS ON FOR A FEW HOURS BEFORE IT WAS IN USE. THE MEDTRONIC REP REPORTED THAT THE ISSUE WORSENED THE LONGER THE SYSTEM WAS ON AND THAT THE ISSUE PERSISTED WITH EACH INSTRUMENT. SITE WAS STILL ABLE TO COMPLETE THE CASE SUCCESSFULLY WITH THE USE OF THE LANDMARX EVOLUTION SYSTEM. THERE WAS NO IMPACT ON PT'S 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 46 YR