BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6980538 · Received October 26, 2017

    Report

    Report Number
    1723170-2017-04331
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 29, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994653482
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO SITE TO TEST THE EQUIPMENT. REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. A SYSTEM CHECKOUT WAS PERFORMED AND THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS WERE REPLACED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE LOGS FOR THE NAVIGATION SYSTEM WERE REVIEWED BY MEDTRONIC PERSONNEL. HOWEVER, THE LOGS PROVIDED NO ADDITIONAL INSIGHT INTO THE PROBABLE CAUSE OF THE ANOMALY. THE BEHAVIOR OF THE REPORTED ISSUE WAS FOUND TO BE CONSISTENT WITH A KNOWN ANOMALY IN THE MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, WHEN ON "SELECT PROCEDURE" SCREEN THE NAVIGATION SYSTEM BECAME UNRESPONSIVE. SITE HARD SHUTDOWN THE RACK AND NAVIGATION INTERFACE UNIT (NIU). AFTER WAITING FOR ABOUT A MINUTE THE NAVIGATION INTERFACE UNIT (NIU) WAS TURNED ON AND THEN THE RACK WAS TURNED ON. UPON BOOTING UP THE SYSTEM FUNCTIONED NORMALLY. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760465 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7 00613994653482

    Patients

    Seq Age Sex Outcome Treatment
    1