BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX ELEMENT OR ENT

    MDR report key: 3254154 · Received July 30, 2013

    Report

    Report Number
    1723170-2013-00560
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FROM SITE. MEDTRONIC REPRESENTATIVE FOLLOWING-UP AT THE SITE CONFIRMED NO CORE FILES IN DIRECTORY; CHECKED THE HD SPACE FOR ADEQUATE AVAILABILITY; RE-STARTED AND VERIFIED THE APPLICATION WAS FUNCTIONING PROPERLY. SOFTWARE INVESTIGATION COMPLETED. INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE ROOT CAUSE OF EVENT. NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, PHYSICIAN, REPORTED THAT WHILE NAVIGATING IN AN ENT PROCEDURE, USING LANDMARX, THE SOFTWARE UNEXPECTEDLY EXITED TO THE LAUNCH SCREEN. A RE-BOOT OF THE SYSTEM ALLOWED THEM TO RE-ENTER THE APPLICATION, IT JUMPED TO THE NAVIGATION SCREEN, AND WHEN ATTEMPTING TO GO BACK A STEP, IT JUMPED TO THE SELECT PATIENT TASK. THE SURGEON STATED THAT IN 'NAVIGATE' HE COULD SEE THE REFERENCE FRAME AND PROBE IN THE TRACKING VIEW, HOWEVER, CROSSHAIRS REMAINED RED AND THE IMAGES WERE STATIONARY. THE PATIENT WAS RE-REGISTERED AND THE SOFTWARE BEHAVED AS EXPECTED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354662 LANDMARX ELEMENT OR ENT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. ELEMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR