BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 SYSTEM

    MDR report key: 8290087 · Received January 30, 2019

    Report

    Report Number
    1723170-2019-00460
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 25, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994665928
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE POWER CORD FOR THE NAVIGATION INTERFACE UNIT (NIU) WAS UNPLUGGED. THE POWER CORD WAS PLUGGED IN, AND THE ISSUE RESOLVED. THE SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. ADDITIONAL INFORMATION/REVIEW DETERMINED THAT THE CAUSE OF THE EVENT WAS TRACED TO THE USER. 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 BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT PRE-OPERATIVELY, THE SYSTEM DISPLAYED "LOCALIZER NOT CONNECTED". THE SYSTEM WAS RESTARTED FOUR TIMES WITHOUT RESOLVE. THE SITE USED A DIFFERENT NAVIGATION SYSTEM TO CONTINUE THE CASE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND THERE WAS NO SURGICAL DELAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVED WITH THE CASE. THE SYSTEM WAS BOOTED IN THE MORNING WITH NO PATIENT PRESENCE. IT WAS NOTED THAT THE CAUSE OF THE ISSUE WAS THAT THE NIU CONTROL BOX WAS UNPLUGGED. THE SITES BIOMED WAS MADE AWARE AND IT WAS NOTED THAT THE BOOM HAD BEEN MOVED AND THE CONTROL BOX UNPLUGGED. THE SITE USED ANOTHER NAVIGATION SYSTEM FOR THE CASE THAT OCCURRED THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83885 STEALTHSTATION I7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734062 00613994665928

    Patients

    Seq Age Sex Outcome Treatment
    1