BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2182255 · Received July 12, 2011

    Report

    Report Number
    1723170-2011-01216
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT WAS PRESENT AT TIME OF EVENT. PER RMA, A REPLACEMENT CAMERA WAS SENT TO SITE. UPON RETURN OF SUSPECT CAMERA, EVAL SHOWS, PASSIVE TRACKING WAS FOUND TO BE REDUCED TO LESS THAN 6 FEET AFTER WARM UP. THE PSU PASSED AN AAK TEST AT .06MM BUT WITH VERY HIGH LINE SEPARATION OF 2.63MM. THE LINE SEPARATION WAS ADJUSTED TO .09MM. THE PSU PASSED SUBSEQUENT FUNCTIONAL AND AAK TESTS AND IS NOW FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THAT WHEN THE CAMERA ON THE EVOLUTION SYSTEM WAS POINTED DIRECTLY AT THE PT TRACKER, TRACKING WAS RED STATUS. WHEN THE CAMERA WAS TURNED SLIGHTLY TO ONE SIDE, TRACKING WENT GREEN STATUS. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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