BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2040347 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00649
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. A CONTINUITY TEST REVEALED AN OPEN FROM PIN 11 OF THE 12 PIN LEMO CONNECTOR TO PIN 2 OF THE DB9 CONNECTOR. WHILE NO PT WAS PRESENT, THIS ISSUE IS BEING REPORTED BECAUSE IF THIS ISSUE OCCURRED DURING SURGERY, IT COULD LEAD TO AN UNEXPECTED LOSS OF NAVIGATION, WHICH COULD LEAD TO PT HARM.

    Description of Event or Problem · 1

    A SITE REP, CLINICAL ENGINEER, REPORTED THAT THE CAMERA WAS CONTINUOUSLY CYCLING ON THEIR LANDMARX EVOLUTION SYSTEM. THE CABLE CONNECTION TO THE CAMERA LOOKED FULLY SEATED WITH NO VISIBLE DAMAGE TO THE CABLE. NO PT PRESENT, THIS WAS FOUND BEFORE THE START OF THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE