BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX ELEMENT

    MDR report key: 2193618 · Received July 13, 2011

    Report

    Report Number
    1723170-2011-01229
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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

    SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED THE SURGEON ALLEGED AN INACCURACY OF 1 OR 2 MM DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THE SURGEON REGISTERED WITH TRACER AND FELT ACCURATE AFTER CHECKING SEVERAL ANATOMICAL LANDMARKS. WHEN HE WAS NAVIGATING IN THE NOSE, HE FELT INACCURATE 1 TO 2 MM TO THE LEFT WHILE USING THE STRAIGHT SUCTION. THERE WERE NOT ANY ISSUES REGISTERING THE INSTRUMENT AND THE PT EXAM LOOKED CLEAR; NO ARTIFACT OR SCATTER. THE SURGEON PROCEEDED WITH THE CASE TO COMPLETION WITH THE USE OF THE LANDMARX ELEMENT SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARX ELEMENT STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. ELEMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR