BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSTIM NAVIGATED BRAIN STIMULATION SYSTEM

    MDR report key: 6546956 · Received May 5, 2017

    Report

    Report Number
    3007147067-2017-00001
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    February 16, 2017
    Report Date
    March 15, 2017
    Manufacturer
    NEXSTIM PLC
    Product Code
    HAW
    UDI-DI
    06430063200057
    PMA / PMN Number
    K112881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S STATEMENT: THIS IS NEXSTIM'S FIRST MDR. EVEN IF NEXSTIM'S RISK AND REPORTABILITY ASSESSMENT REF: (B)(4) HAS DEMONSTRATED THE EVENT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT TO FDA NEXSTIM WANTS TO REPORT AS IT HAS BEEN REPORTED TO FINNISH COMPETENT AUTHORITY VALVIRA. THE REPORT WAS INITIALLY SENT TO FDA ON MARCH 15, 2017 ON A PAPER FORMAT DUE TO TECHNICAL DIFFICULTIES NEXSTIM HAS HAD WITH SETTING UP FULLY FUNCTIONAL AND VALIDATED ESG ACCOUNT. THE PAPER FORMAT WAS REJECTED BY FDA AND IT WAS RETURNED TO NEXSTIM (RECEIVED ON APRIL 3, 2017). AT THAT TIME, NEXSTIM HAD STILL NOT BEEN ABLE TO RESOLVE THE TECHNICAL ISSUES AND AN EXTERNAL IT EXPERT WAS CALLED IN TO HELP WITH THE ELECTRONIC CERTIFICATE CONVERSION TO ESG-ACCEPTABLE FORMAT (GLOBALSIGN'S PFX-FORMAT HAD TO BE CONVERTED INTO CER-FORMAT). THE PRODUCTION ESG WAS FINALLY UP AND RUNNING ON MAY 6, 2017 AFTER SUCCESSFUL PRE-PRODUCTION CONNECTIVITY AND COMPLIANCE TEST REPORTS, JAVA UPDATES AND INTERNET EXPLOXER CONFIGURATION CHANGES. PROBLEM DESCRIPTION: WHEN A USER, WHILE COPYING MR IMAGE SERIES INTO THE NBS SYSTEM, ACCIDENTALLY GENERATES DUPLICATE COPY OF ONE OR SEVERAL FILES, NBS SOFTWARE WILL IN CERTAIN CIRCUMSTANCES, INCORRECTLY INTERPRET LEFT-RIGHT ORIENTATION AND DISPLAY THE HEAD 3D MODEL MIRRORED ON THE NBS SYSTEM DISPLAY. IF MR IMAGES ARE TRANSFERRED AS INSTRUCTED AND TRAINED, WITHOUT DUPLICATE COPIES, MIRRORING ON THE NBS DISPLAY WILL NOT HAPPEN. MIRRORING IS LIMITED ONLY TO HOW NBS DISPLAYS THE MR INFORMATION. THE DICOM EXPORT FUNCTION OF THE NBS SYSTEM MAINTAINS THE ORIGINAL ORIENTATION OF THE ANATOMICAL MRI. THE APPARENT LOCATION OF NBS MAPPING RESPONSES, WHEN VIEWED OUTSIDE OF NBS (E.G. IN NEURONAVIGATORS), WILL THEREFORE NOT CONCUR WITH THE PHYSICALLY MAPPED HEMISPHERE MAKING THE GENERATED NBS MAP UNUSABLE FOR PRE-PROCEDURAL PLANNING PURPOSES. INDICATIONS FOR USE: THE NEXSTIM NAVIGATED BRAIN STIMULATION SYSTEM (NBS SYSTEM) IS INDICATED FOR NONINVASIVE MAPPING OF THE PRIMARY MOTOR CORTEX OF THE BRAIN TO ITS CORTICAL GYRUS. THE NBS SYSTEM PROVIDES INFORMATION THAT MAY BE USED IN THE ASSESSMENT OF THE PRIMARY MOTOR CORTEX FOR PRE-PROCEDURAL PLANNING. THE NBS SYSTEM IS NOT INTENDED TO BE USED DURING A SURGICAL PROCEDURE. THE NBS SYSTEM IS INTENDED TO BE USED BY TRAINED CLINICAL PROFESSIONALS. SAFETY EVALUATION: THE ISSUE HAS NOT CAUSED DEATH OR SERIOUS INJURY. BASED ON THE RISK ASSESSMENT REF: (B)(4) THE ISSUE IS NOT LIKELY TO CAUSE DEATH OR SERIOUS INJURY EVEN IF THE MALFUNCTION WOULD RECUR. THE PROBLEM IS HIGHLY DETECTABLE AT NUMEROUS CONTROL POINTS BEING IN PLACE IN THE SURGICAL PLANNING PROCEDURES. THE PRODUCT PROVIDES INFORMATION THAT MAY BE USED IN THE ASSESSMENT OF THE PRIMARY MOTOR CORTEX FOR PRE-PROCEDURAL PLANNING AND THE INFORMATION IT PROVIDES IS ONLY INDICATIVE WITH RESPECT TO THE BRAIN ANATOMY. IT SHALL BE ALWAYS CONFIRMED BY OTHER EXAMINATIONS. PLANNED ACTION: NEXSTIM IS PLANNING TO UPDATE NBS SYSTEM 4 AND NBS SYSTEM 5 SOFTWARE AT THE CUSTOMER SITES TO MAKE THE PRODUCTS MORE ROBUST AGAINST USER ERROR. A SOFTWARE UPDATE FOR NBS SYSTEM 4 AND NBS SYSTEM 5 WILL BE IMPLEMENTED DURING ANNUAL SERVICE VISITS OVER THE NEXT 12 MONTHS.

    Description of Event or Problem · 1

    THIS IS NEXSTIM'S FIRST MDR AND NEXSTIM WANTS TO SELECT MOST CONSERVATIVE APPROACH. NEXSTIM WANTS TO REPORT IT DESPITE NEXSTIM'S RISK AND REPORTABILITY ASSESSMENT REF: (B)(4) HAS DEMONSTRATED THE EVENT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT TO FDA BECAUSE IT HAS BEEN ALSO REPORTED TO FINNISH COMPETENT AUTHORITY VALVIRA. THE REPORT WAS INITIALLY SENT TO FDA ON MARCH 15, 2017 ON A PAPER FORMAT DUE TO TECHNICAL DIFFICULTIES NEXSTIM HAS HAD WITH SETTING UP FULLY FUNCTIONAL AND VALIDATED ESG PRODUCTION ACCOUNT. THE PAPER FORMAT WAS REJECTED BY FDA AND IT WAS RETURNED TO NEXSTIM (RECEIVED ON APRIL 3, 2017). THE PROBLEM: NEXSTIM HAS BECOME AWARE OF AN ISSUE WITH THE NBS SYSTEM 4 SOFTWARE WHICH ALSO AFFECTS NBS SYSTEM 5 SOFTWARE. WHEN A USER, WHILE COPYING MR IMAGE SERIES INTO THE NBS SYSTEM, ACCIDENTALLY GENERATES DUPLICATE COPY OF ONE OR SEVERAL FILES, NBS SOFTWARE WILL IN CERTAIN CIRCUMSTANCES, INCORRECTLY INTERPRET LEFT-RIGHT ORIENTATION AND DISPLAY THE HEAD 3D MODEL MIRRORED ON THE NBS SYSTEM DISPLAY. IF MR IMAGES ARE TRANSFERRED AS INSTRUCTED AND TRAINED, WITHOUT DUPLICATE COPIES, MIRRORING ON THE NBS DISPLAY WILL NOT HAPPEN. MIRRORING IS LIMITED ONLY TO HOW NBS DISPLAYS THE MR INFORMATION. THE DICOM EXPORT FUNCTION OF THE NBS SYSTEM MAINTAINS THE ORIGINAL ORIENTATION OF THE ANATOMICAL MRI. THE APPARENT LOCATION OF NBS MAPPING RESPONSES, WHEN VIEWED OUTSIDE OF NBS (E.G. IN NEURONAVIGATORS), WILL THEREFORE NOT CONCUR WITH THE PHYSICALLY MAPPED HEMISPHERE MAKING THE GENERATED NBS MAP UNUSABLE FOR PRE-PROCEDURAL PLANNING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328167 NEXSTIM NAVIGATED BRAIN STIMULATION SYSTEM NEXSTIM NBS SYSTEM 4, NEXSTIM NBS SYSTEM 5 HAW NEXSTIM PLC NBS SYSTEM 4 06430063200057

    Patients

    Seq Age Sex Outcome Treatment
    1