BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2052105 · Received March 1, 2011

    Report

    Report Number
    1723170-2011-00171
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 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

    THE REPORTED ISSUE COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SOFTWARE WAS REINSTALLED AND THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED 2D VIEWS WENT BLACK WHILE IN NAVIGATION DURING AN ENT PROCEDURE. THEY WENT BACK AND FORTH ONE SCREEN WHICH RESOLVED THE ISSUE. THE SURGEON OPTED TO CONTINUE THE SURGERY WITH THE USE OF THE NAVIGATION SYSTEM THERE WAS NO IMPACT ON 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 18 YR