BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2201101 · Received July 29, 2011

    Report

    Report Number
    1723170-2011-01249
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 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 REPRESENTATIVE REPORTED INACCURACY DURING A PROCEDURE. FOR THIS CRANIAL CASE, THE SURGEON PERFORMED A SUCCESSFUL PT REGISTRATION AND VERIFIED ACCURACY. THE SURGEON PROCEEDED TO USE THE PASSIVE PLANAR BLUNT AND NOTED A 1 CM INACCURACY AT THE TIP OF THE PT'S NOSE. WHEN TOUCHING THE TIP OF THE PT'S NOSE, IT APPEARED AS IF THE INSTRUMENT WAS 1 CM ANTERIOR TO THE TIP OF THE CAD MODEL. THE SURGEON DISCONTINUED THE USE OF THE NAVIGATION SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR