BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6065964 · Received October 30, 2016

    Report

    Report Number
    1723170-2016-02773
    Event Type
    Malfunction
    Date Received
    October 30, 2016
    Date of Event
    October 4, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994653482
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. ON 10/04/2016, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT WHILE ATTEMPTING TO USE THEIR NAVIGATION SYSTEM, THEIR IMAGING SYSTEM DISPLAYED AN ORANGE LINE OF COMMUNICATION. WALKED THE SURGEON THROUGH UPDATING THE IMAGING SYSTEM NETWORKING INFORMATION AND CONFIRMED FUNCTIONALITY. IDENTIFIED THE POWER SOURCE FOR THE NAVIGATION INTERFACE UNIT (NIU) HAD COME LOOSE. RE-PLUGGED THE NIU, BOOTED THE SYSTEM AND THE CAMERA FUNCTIONED NORMALLY. USB VIEWER SHOWS ALL CONNECTIVITY. ON 10/05/2016, A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. NO PARTS WERE REPLACED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOW PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SURGEON ALLEGED THEY WERE UNABLE TO TRACK INSTRUMENTS WITH THEIR NAVIGATION SYSTEM. IN TROUBLE-SHOOTING, THEY CHECKED THE TRACKING VIEW AND FOUND THE CAMERA WAS NOT COMMUNICATING BUT DISPLAYING A RED-X. THERE WERE TWO GREEN LIGHTS ON THE NAVIGATION SYSTEM CAMERA AND RE-BOOTING THE NAVIGATION SYSTEM DID NOT RESOLVE THE ISSUE. NO FURTHER DETAILS REGARDING THE BEHAVIOR, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. A SECOND NAVIGATION SYSTEM WAS BROUGHT IN TO USE IN CONTINUING THE PROCEDURE TO COMPLETION. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716833 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7 00613994653482

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4)