BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 2506466 · Received March 27, 2012

    Report

    Report Number
    1045254-2012-00098
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Report Date
    March 1, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA. WITHOUT PATIENT INJURY, THIS EVENT IS BEING FILED AS A PRODUCT PROBLEM. A REVIEW OF THIS PRODUCT'S COMPLAINT HISTORY SHOWS THAT A PATIENT INJURY HAS PREVIOUSLY OCCURRED FROM THE ALLEGED COMPLAINT MALFUNCTION MODALITY, HOWEVER, THIS MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY BASED ON THE FDA'S DEFINITION OF "LIKELY" IF IT WERE TO RECUR. NO EVENT DATE PROVIDED. (B)(4). COMPLETED BY SERVICE AND REPAIR - TESTING / REPAIR EVALUATION DID NOT CONFIRM THE REPORTED EVENT; THE UNIT PASSED ALL MANUFACTURING SPECIFICATION. NO USABILITY ISSUES OR OUT OF SPECIFICATION CONDITIONS WERE IDENTIFIED DURING THE REPAIR. THE DEVICE WAS TESTED TO SPECIFICATIONS PER SRI NIM 4 <(>&<)> 8 CH PI STIM CNTRL, REV E. RESULTS CODE - ENTERED TO FACILITATE EMDR SUBMISSION. CONCLUSIONS CODE - DEVICE DESCRIPTION THE NIM-RESPONSE NERVE MONITORING SYSTEMS MONITOR 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. IF THERE IS A CHANGE IN NERVE FUNCTION, THE NIM SYSTEM MAY PROVIDE VISUAL AND AUDIBLE WARNINGS TO ALERT YOU. THIS HELPS REDUCE THE RISK OF NERVE DAMAGE DURING VARIOUS SURGERIES, INCLUDING ENT AND GENERAL SURGICAL PROCEDURES, IMPROVING SAFETY AND PEACE-OF-MIND FOR BOTH SURGEONS AND PATIENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SCHEDULED SURGERY, THERE WERE SPONTANEOUS CHANGES IN SENSITIVITY SETTINGS WITHOUT PROMPTING. THERE WAS NO ALLEGATION OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8252800 RESPONSE 2.0 INCREMENT STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8252800 52763300

    Patients

    Seq Age Sex Outcome Treatment
    1