BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 2480722 · Received March 6, 2012

    Report

    Report Number
    1045254-2012-00043
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 7, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE DESCRIPTION: THIS NERVE MONITORING 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 PATIENT INTERFACE AND CABLE PROVIDE THE MEANS FOR CARRYING ELECTROMYOGRAPHIC ACTIVITY FROM THE PATIENT'S INNERVATED MUSCLES TO THE CONSOLE, AN INTERFACE FOR CARRYING STIMULATION SIGNALS FROM THE CONSOLE TO THE STIMULATING PROBES/ELECTRODES, AND AN INTERFACE TO THE CONSOLE FROM THE INCREMENTING PROBE. THE PATIENT INTERFACE HAS FOUR OR EIGHT COLOR CODED PAIRS OF PATIENT ELECTRODE JACKS, A PATIENT ELECTRODE GROUND JACK, ONE STIMULUS RETURN JACK, TWO STIMULUS OUTPUT JACKS (CONFIGURED TO ACCEPT MONOPOLAR OR BIPOLAR STIMULATING PROBES), AND ONE INCREMENTING PROBE JACK. THE PATIENT SIMULATOR IS USED FOR TROUBLESHOOTING AND DEMONSTRATING THE SYSTEM WITHOUT THE NEED FOR PATIENT INTERACTION. THE MUTING DETECTOR PROBE IS DESIGNED TO DETECT THE PRESENCE OF ELECTRONIC NOISE FROM EXTERNAL DEVICES (SUCH AS ELECTROCAUTERY / ELECTROSURGICAL UNIT) THAT MAY CAUSE INTERFERENCE ON THE EMG MONITOR.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS RECEIVED ON (B)(4), 2012. THE CONSOLE AND PATIENT INTERFACE CABLE WERE EXAMINED BY SERVICE <(>&<)> REPAIR RESULTING IN NFF (NO FAULT FOUND). IN A TELECONFERENCE WITH THE SURGEON ON (B)(6), 2012, THE DOCTOR STATED THAT THE NERVES WERE CONFIRMED TO BE INTACT THROUGH STIMULATION WITH THE NIM SYSTEM PRIOR TO CLOSING THE SURGICAL SITE. THEREFORE, THE NIM SYSTEM WAS FUNCTIONING PROPERLY DURING SURGERY. THE RISK MANAGEMENT REPORT WILL NOT BE REVIEWED DUE TO NFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SCHEDULED THYROID PROCEDURE USING A NERVE INTEGRITY MONITORING SYSTEM, THE PATIENT AWOKE FROM THE ANESTHESIA WITH STRIDOR AND APPARENTLY A VOCAL FOLD PARALYSIS. IT WAS ALSO REPORTED THAT "IT WAS A DIFFICULT CASE DUE TO SCARRING AND SIZE OF GOITER. BOTH NERVES IDENTIFIED AND WERE INTACT. BOTH NERVES DID STIMULATE PRIOR TO CLOSURE. IF NERVES STIMULATE, USUALLY GOOD OUTCOME. NOT SO IN THIS CASE. PATIENT'S LONG TERM PROGNOSIS IS REPORTED AS "GUARDED.""

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8253001 NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Disability PROBE (B)(4) 5PK STD PRASS FLUSH TIP,