BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 2605401 · Received June 8, 2012

    Report

    Report Number
    1045254-2012-00334
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 18, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DESCRIPTION: THE NIM NEURO 3.0 IS AN EIGHT-CHANNEL THE NIM-RESPONSE 3.0 IS A FOUR-CHANNEL EMG MONITOR FOR INTRAOPERATIVE USE DURING SURGERIES IN WHICH A NERVE IS AT RISK DUE TO UNINTENTIONAL MANIPULATION. THE NIM 3.0 SYSTEM 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. INDICATIONS FOR USE: THE NIM 3.0 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 APS-ELECTRODE IS AN ACCESSORY INTENDED FOR PROVIDING AUTOMATIC PERIODIC STIMULATION TO NERVES WHEN USED WITH THE MEDTRONIC NERVE MONITORING SYSTEMS. INDICATIONS FOR NIM 3.0 EMG MONITORING PROCEDURES INCLUDE: INTRACRANIAL, EXTRACRANIAL, INTRATEMPORAL, EXTRATEMPORAL, NECK DISSECTIONS, THORACIC SURGERIES, AND UPPER AND LOWER EXTREMITIES INDICATIONS FOR SPINAL PROCEDURES WHICH MAY USE NIM 3.0 EMG MONITORING INCLUDE: DEGENERATIVE TREATMENTS, PEDICLE SCREW PROCEDURES, FUSION CAGES, RHIZOTOMY, ORTHOPEDIC SURGERY, OPEN AND PERCUTANEOUS LUMBAR AND CERVICAL SURGICAL PROCEDURES, AND THORACIC SURGICAL PROCEDURES. WARNINGS AND PRECAUTIONS INCLUDE, BUT ARE NOT LIMITED TO: THE NIM DOES NOT PREVENT THE 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. SAFE STIMULUS LEVELS ARE DEPENDENT ON VARIOUS CONDITIONS INCLUDING BUT NOT LIMITED TO: TYPE OF EXCITABLE TISSUE, CHARGE PER PULSE, AND CHARGE PER UNIT AREA. WAVEFORM MORPHOLOGY, REPETITION RATE, AND STIMULATOR EFFECTIVE SURFACE AREA MUST BE CONSIDERED. PATIENT INTERFACE ID# (B)(4) SN# (B)(4), LOT# 66494100 (MFR DATE 03/16/2010); MUTING PROBE ID# (B)(4), SN# UNKNOWN, LOT# UNKNOWN [NOTE: THE MUTING DETECTOR PROBE IS DESIGNED TO DETECT THE PRESENCE OF ELECTRONIC NOISE FROM EXTERNAL DEVICES (SUCH AS ELECTROC AUTERY/ELECTROSURGICAL UNIT) THAT MAY CAUSE INTERFERENCE ON THE EMG MONITOR]. (B)(4). THE NIM SYSTEM MAINFRAME AND INTERFACE WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND ANALYSIS BY QUALITY ENGINEERING. THE CUSTOMER'S MAINFRAME AND PATIENT INTERFACE WERE USED; SERVICE AND REPAIR PROVIDED A PATIENT SIMULATOR AND INCREMENTING PROBE. THE PATIENT INTERFACE WAS CONNECTED TO THE MAINFRAME AND THE SIMULATOR AND PROBE WERE CONNECTED TO THE INTERFACE. THE MAINFRAME WAS POWERED ON; ALL SELF-CHECKS PASSED DURING BOOT-UP. A MONITORING SCREEN WAS USED DISPLAYING ALL AVAILABLE CHANNELS. EACH CHANNEL WAS STIMULATED IN TURN AND THE MAINFRAME DISPLAYED THE NORMAL, EXPECTED RESPONSES. THE STIMULUS LEVEL WAS SUCCESSFULLY INCREASED AND DECREASED BY USING THE INCREMENTING PROBE SWITCH (BOTH STIM 1 AND STIM 2 WERE CHECKED). THE INTERFACE CABLE CONNECTOR WAS STRESSED WHILE THE CHANNELS WERE STIMULATED, AND THERE WAS NO CHANGE TO THE RESPONSES DISPLAYED. THE ELECTRODE CHECK SCREEN WAS ALSO CHECKED; ALL IMPEDANCE READINGS WERE WITHIN THE PROPER RANGES (INCLUDING STIM 1, STIM 2, AND GROUND). NO FUNCTIONAL ISSUES WERE IDENTIFIED DURING THE EVALUATION. THE SYSTEM WAS DELIVERED TO BE SUBJECTED TO THE REPAIR PROCESS AND RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED FACIAL PARALYSIS DURING A REVISION RIGHT EAR MASTOIDECTOMY PROCEDURE. IT WAS NOTED THAT THE ELECTRODES WERE PLACED OFF-LABEL LOCATIONS ON THE PATIENT DURING PRE-OPERATIVE PREPARATION. REPORTEDLY, THERE WERE AUDIO-TONE WARNINGS TO SIGNAL PRESENCE OF A NERVE BUT THE WARNINGS WERE INADVERTENTLY DISMISSED AS THE PATIENT BEING "LIGHT". IT WAS NOT CONFIRMED IF THERE WERE BILATERAL OR UNILATERAL ACTIVITY ON THE AUDIO TONE WARNINGS. APPROXIMATELY FORTY-FIVE MINUTES INTO THE PROCEDURE, A FACIAL NERVE WAS SEEMINGLY STIMULATED BUT NO AUDIO EVENT OCCURRED. IT WAS NOTED THAT THE BASELINE VOLTAGE AT STIMULUS WAS NOT VERIFIED. DURING A CLEAR AUDIO EVENT DURING NERVE STIMULATION IT APPEARED THE ALARM WAS BYPASSED THE PROCEDURE CONTINUED. POST-OPERATIVE EXAMINATION OF THE PATIENT IDENTIFIED WHAT APPEARED TO BE PARTIAL PARALYSIS ON THE RIGHT SIDE OF THE MOUTH. NERVE TESTING WITH A HAND-HELD STIMULUS DID, HOWEVER, CONTORT THE RIGHT SIDE OF THE FACE AND MOUTH WHICH MAY INDICATE SOME REMAINING NERVE INTEGRITY WITH POSSIBLE NON-PERMANENT PARALYSIS. THE OR NURSE NOTED THAT DURING PRE-OPERATIVE PREP OF THE PATIENT PRIOR TO INTUBATION, THE PATIENT DEMONSTRATED A "BIT OF DRAG ON THE RIGHT SIDE OF THE PATIENTS MOUTH". FOLLOW-UP WITH THE CUSTOMER FOUND THE PATIENT IS DOING FINE BUT IS STILL SYMPTOMATIC ON THE RIGHT SIDE OF THE MOUTH AND FACE AND IS PLANNING ON GOING TO ANOTHER PHYSICIAN FOR EXAMINATION AND FOLLOW -UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8253001 62057100

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Disability