BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S7 STEALTHSTATION NAVIGATION SYSTEM

    MDR report key: 9046328 · Received September 13, 2019

    Report

    Report Number
    1723170-2019-04879
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    September 6, 2019
    Report Date
    January 9, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE COMPUTER OF THE NAVIGATION SYSTEM WAS REPLACED TO RESTORE FUNCTIONALITY. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735225R, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE COMPUTER WITH LOT NUMBER 1834347 WAS RETURNED TO MEDTRONIC FOR ANALYSIS. ANALYSIS REVEALED THAT DURING INITIAL POWER UP THE COMPUTER STARTED POWER CYCLING ON ITS OWN AND WOULD NOT BOOT. AFTER RE-SEATING THE RAM MODULES THE COMPUTER BOOTED NORMALLY TO THE APPLICATION SCREEN AND PASSED TESTING. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM BECOMES UNRESPONSIVE WHEN BOOTING UP AND ENTERING THE APPLICATION SOFTWARE. IT WAS NOTED THAT THE NAVIGATION SYSTEM WOULD NOT POWER OFF WITH PROMPTS AND ONLY WHEN UNPLUGGING THE SYSTEM FROM A KNOWN OPERATIONAL OUTLET. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820013 S7 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1