BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM®

    MDR report key: 5752594 · Received June 27, 2016

    Report

    Report Number
    1045254-2016-00209
    Event Type
    Injury
    Date Received
    June 27, 2016
    Report Date
    June 3, 2016
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: -- NIM EMG TUBE, PRODUCT NUMBER AND LOT NUMBER UNKNOWN -- NIM STIMULATING PROBE, PRODUCT NUMBER AND LOT NUMBER UNKNOWN. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; NO DEVICES RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS FILE IS TO REVIEW THE ARTICLE "THE LEARNING CURVE FOR INTRAOPERATIVE NEUROMONITORING OF THE RECURRENT LARYNGEAL NERVE IN THYROID SURGERY", WOJTCZAK, ET AL, LANGENBECKS ARCH SURG, DOI 10.1007/S00423-016-1438-8. "THE AIM OF THIS STUDY WAS TO EVALUATE THE LEARNING CURVE FOR IONM" "OF THE RLN AT AN ACADEMIC CENTER". METHODS: "A 3-YEAR PERIOD (2012-2014) OF WORKING WITH IONM (NIM3.0, MEDTRONIC) WAS PROSPECTIVELY ANALYZED WITH A SPECIAL EMPHASIS ON COMPARING THE INITIAL IMPLEMENTATION PHASE IN 2012 (101 PATIENTS, 190 RLNS AT RISK) WITH SUBSEQUENT YEARS OF IONM USE IN 2013 (70 PATIENTS, 124 RLNS AT RISK) AND 2014 (65 PATIENTS, 120 RLNS AT RISK)." RESULTS: "THE RATE OF SUCCESSFUL IONM-ASSISTED RLN IDENTIFICATION INCREASED GRADUALLY OVER THE 3-YEAR STUDY PERIOD, WITH A CORRESPONDING DECREASE IN THE RATE OF TECHNICAL PROBLEMS." "THE RATE OF RLN INJURIES TENDED TO DECREASE OVER TIME." "IN 2012, OUT OF 190 RLNS AT RISK, 175 (92.11 %) WERE IDENTIFIED WITH IONM. IN SUBSEQUENT YEARS, AN INCREASE IN RLN IDENTIFICATION WITH IONM WAS OBSERVED: IN 2013, OUT OF 124 RLNS AT RISK, 118 (95.16 %) WERE IDENTIFIED, AND IN 2014, OUT OF 120 RLNS AT RISK, 119 (99.16 %) WERE IDENTIFIED." DURING THE 3-YEAR PERIOD WORKING WITH IONM (236 OPERATIONS), PROBLEMS RELATED TO THE SURFACE ELECTRODES ON THE INTUBATION TUBE (7.2 %) WERE MORE FREQUENT THAN PROBLEMS INVOLVING THE GROUNDING ELECTRODES (0.85 %). THE MOST COMMON RECORDING-SIDE PROBLEMS WERE MALPOSITIONING OF THE ENDOTRACHEAL TUBE (5.08 %), THE TUBE BEING INSERTED TOO DEEP (1.27 %), AND THE TUBE SIZE NOT FITTING THE PATIENT ADEQUATELY (0.84 %.). SLIPPAGE OF THE GROUNDING ELECTRODE (0.85 %) WAS OBSERVED ONLY DURING THE FIRST YEAR OF IONM USE." DESPITE SOLID PREPARATION FOR THE INTRODUCTION OF NEUROMONITORING IN THYROID SURGERY, THE AUTHORS DID NOT ENTIRELY AVOID PROBLEMS DURING THE INITIAL STAGE OF IONM USE. THESE WERE PRIMARILY TECHNICAL PROBLEMS, WHICH AROSE NOT FROM ANYTHING DIFFICULT ABOUT THE USE OF THE EQUIPMENT BUT FROM A LACK OF EXPERIENCE WITH IT." THE MOST COMMON TECHNICAL PROBLEM THROUGHOUT THE STUDY PERIOD WAS ROTATION OF THE ELECTRODES ON THE ENDOTRACHEAL TUBE IN RELATION TO THE VOCAL CORDS." WE DID NOT OBSERVE ANY INTRAOPERATIVE RLN STIMULATION ERRORS." IN THE INITIAL PHASE OF IONM USE, WE OBSERVED SIGNAL LOSS IN EIGHT PATIENTS. IN THREE CASES, THERE WAS A FALSE POSITIVE SIGNAL- A NEGATIVE SIGNAL-BUT AFTER THE OPERATION, THERE WAS NO VOCAL CORD PALSY (L2). AMONG FIVE PATIENTS WITH TRUE POSITIVE SIGNALS, SEGMENTAL LOSS OF SIGNAL (LOS TYPE 1) OCCURRED IN TWO PROCEDURES AND GLOBAL LOSS OF SIGNAL (LOS TYPE 2) OCCURRED IN THREE OPERATIONS. IN THE CASES OF LOS TYPE 1, THE NERVE WAS INADVERTENTLY CUT IN ONE CASE AND CRUSHED IN THE OTHER CASE. EXCESSIVE TRACTION WAS THE MAIN CAUSE OF LOS TYPE 2. IN THE LATER PHASE OF IONM USE (2013-2014), THERE WERE FOUR INSTANCES OF LOS; THREE OF THESE WERE TRUE LOSS OF SIGNAL, CAUSED BY TRACTION." THE STUDY DOCUMENTED A TOTAL OF 5 TRANSIENT RLN PARESIS AND 2 PERMANENT RLN PARESIS IN 2012 (OUT OF A TOTAL OF 190 NERVES AT RISK), WITH 3 TRANSIENT PARESIS AND 0 PERMANENT PARESIS IN 2013-2014 (OUT OF A TOTAL OF 244 NERVES AT RISK). CONCLUSION: "THERE WAS A SHARP DECREASE IN THE NUMBER OF TECHNICAL PROBLEMS INVOLVING EQUIPMENT SETUP FROM 2012 TO 2014." THERE WAS A DECREASE IN THE TOTAL RATE OF RLN PARALYSIS IN THE EARLY POSTOPERATIVE PERIOD; A DESCENDING TREND WAS ALSO OBSERVED IN BOTH TRANSIENT AND PERMANENT NERVE INJURY, ALTHOUGH THE DECREASE WAS NOT AT THE LEVEL OF STATISTICAL SIGNIFICANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406961 NIM® STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. UNKNOWN NIM

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability