BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION PLUS

    MDR report key: 2012162 · Received February 1, 2011

    Report

    Report Number
    1723170-2011-00070
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED THAT THE SITE DAMAGED THE LEFT FRONT CASTER ON THE EVOLUTION PLUS SYSTEM WHILE MOVING IT ACROSS THE STREET TO ANOTHER BUILDING. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARX EVOLUTION PLUS STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION EVOLUTION PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1