BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2781378 · Received October 10, 2012

    Report

    Report Number
    1723170-2012-00564
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF ALLEGED MALFUNCTION. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE SYSTEM'S POSITION SENSOR UNIT (PSU) HAS BEEN RETURNED TO THE MANUFACTURER. TRACKING WAS FOUND TO BE NORMAL THROUGHOUT THE VOLUME DURING FUNCTIONAL TESTING. THE PSU PASSED A PEG BOARD TEST AND POINT MERGE WITHOUT ISSUE. THE PSU PASSED AN AAK TEST AT .43MM WITH MINIMAL LINE SEPARATION OF .67MM. THE PSU WAS FOUND TO BE FULLY FUNCTIONAL. NO PROBLEM FOUND.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHEN SHE WAS TESTING OPTICAL NAVIGATION WITH THE STEALTHSTATION TREON SYSTEM CAMERA, IT WOULD GRADUALLY BECOME INACCURATE. SHE TESTED AT DIFFERENT LOCATIONS IN THE FIELD OF VIEW (FOV) AND AFTER A FEW MINUTES NAVIGATION WOULD BECOME 5MM-1CM INACCURATE. IT WAS REPORTED THAT THE CAMERA HAD BEEN BUMPED RECENTLY. THE ALLEGED MALFUNCTION DID NOT OCCUR DURING SURGERY AND NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1