BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-NEURO 2.0 MAINFRAME

    MDR report key: 3000021 · Received March 8, 2013

    Report

    Report Number
    1045254-2013-00233
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    June 18, 2012
    Report Date
    June 18, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EVAL AND REPAIR FOUND NO FAULT; HOWEVER, SUBSEQUENT FAILURES WERE FOUND RELATED TO BOTH SOFTWARE AND HARDWARE; DSP BOARD FAILURE/CORRUPT SOFTWARE; MAIN BOARD, CPU AND RAM FAILED - BOOT-UP FAILURE. THE NIM SYSTEM IS INTENDED FOR LOCATING AND IDENTIFYING CRANIAL AND PERIPHERAL MOTOR AND MIXED MOTOR-SENSORY NERVES DURING SURGERY, INCLUDING SPINAL CORD AND SPINAL NERVE ROOTS. THE NERVE INTEGRITY MONITOR (NIM) IS AN EMG MONITOR FOR INTRAOPERATIVE USE DURING SURGERIES IN WHICH A NERVE IS AT RISK DUE TO UNINTENTIONAL MANIPULATION. THE NIM RECORDS ELECTROMYOGRAPHIC (EMG) ACTIVITY FROM MUSCLES INNERVATED BY THE AFFECTED NERVE. THE MONITOR WILL ASSIST EARLY NERVE IDENTIFICATION BY PROVIDING THE SURGEON WITH A TOOL TO HELP LOCATE AND IDENTIFY THE PARTICULAR NERVE AT RISK WITHIN THE SURGICAL FIELD. IT WILL CONTINUOUSLY MONITOR EMG ACTIVITY FROM THE MUSCLES INNERVATED BY THE NERVE AT RISK TO MINIMIZE TRAUMA BY ALERTING THE SURGEON WHEN A PARTICULAR NERVE HAS BEEN ACTIVATED. THE MONITOR UTILIZES TOUCH SCREEN AND COLOR GRAPHIC USER INTERFACE (GUI) ALONG WITH THE AUDIO FEEDBACK TO INCREASE THE USABILITY OF THE DEVICE. WHEN INFORMATION SUGGESTS THAT THE NIM EQUIPMENT MALFUNCTIONS, IT IS ASSUMED THAT THE FAILURE WAS DEVICE-RELATED AND MAY HAVE GONE UNDETECTED. IN THIS CASE, THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF FIELD OBSERVATION. THEREFORE, WITHOUT INFORMATION TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE NIM SYSTEM DOES NOT PREVENT SURGICAL SEVERING OF NERVES. IF MONITORING IS COMPROMISED, THE SURGICAL PRACTITIONER MUST RELY ON ALTERNATE METHODS, OR SURGICAL SKILLS, EXPERIENCE, AND ANATOMICAL KNOWLEDGE TO PREVENT DAMAGE TO NERVES.

    Description of Event or Problem · 1

    THE MFR HAS REFINED CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE. THE MAINFRAME WAS RETURNED FOR SERVICE/REPAIR ALLEGING THE DEVICE WAS WORKING INTERMITTENTLY. ALTHOUGH IN THIS CASE THE FAULT WAS OBSERVED PREOPERATIVELY, AN INTERMITTENT RESPONSE MAY SUGGEST A POTENTIAL INABILITY TO IDENTIFY A NERVE (FALSE NEGATIVE) AND COULD POSSIBLY, UPON RECURRENCE, RESULT IN PT INJURY, I.E. NERVE RESECTION BY THE SURGEON. THE NIM SYSTEM HAS BUILT IN ALARMS AND WARNINGS TO ALERT USERS OF A SYSTEM FAILURE. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER WAS AWARE OF SUCH ALERTS. THIS REPORTED EVENT HAS NO REFERENCE TO AN ALARM OR WARNING; THEREFORE, IT MUST BE ASSUMED THAT AN ALARM OR WARNING WENT UNDETECTED OR DID NOT OCCUR. HARDWARE AND SOFTWARE FAILURES WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98790 NIM-NEURO 2.0 MAINFRAME ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8253001 205774042

    Patients

    Seq Age Sex Outcome Treatment
    1