BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM

    MDR report key: 10115606 · Received June 3, 2020

    Report

    Report Number
    1723170-2020-01584
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    March 2, 2020
    Report Date
    June 3, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SOFTWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE THROUGH REVIEW OF THE REPORTED ISSUE. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID #: 9735740; SOFTWARE VERSION # : 1.2.0. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT DURING A LIVE SPINE CT+FLUORO PROCEDURE, ATTEMPTED A NEW REGISTRATION AFTER ONE SUCCESSFUL REGISTRATION, WITH EXPLICITLY SKIPPING THROUGH "EMPTY IMAGE" AND DOING MANUAL ACQUISITION FOR BOTH AP AND LAT IMAGES USING A SAME IMAGE (LAST CAPTURED BY THE C-ARM). WAS ABLE TO ADVANCE UP TO "DEFINE CENTER POINT", BUT THEN WAS UNABLE TO TOUCH AND DEFINE CENTER POINTS. ALSO, "FLOUROMERGE RESTART" BUTTON WAS GRAYED OUT, AND NAVIGATION TASK UNAVAILABLE (GRAYED OUT). USER CAN WORK AROUND THE ISSUE BY LEAVING THE PROCEDURE AND DELETING THE PRE-OP EXAM, THEN RE-IMPORTING THE EXAM AND RESTARTING THE PROCEDURE. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577323 NAVIGATION STEALTH STATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1