BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® CAPITAL ACCESSORY

    MDR report key: 7734299 · Received July 31, 2018

    Report

    Report Number
    1045254-2018-00336
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    January 1, 2016
    Report Date
    October 2, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS WAS PERFORMED AS THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CHIANG F, LU I, CHANG P, DIONIGI G, RANDOLPH G, SUN H, LEE K, TAE K, JI Y, KIM S, LEE H, WU C. COMPARISON OF EMG SIGNALS RECORDED BY SURFACE ELECTRODES ON ENDOTRACHEAL TUBE AND THYROID CARTILAGE DURING MONITORED THYROIDECTOMY. KAOHSIUNG JOURNAL OF MEDICAL SCIENCES. 2017; 33, 503-509. THE PURPOSE OF THIS STUDY WAS TO COMPARE TWO SURFACE RECORDING METHODS THAT WERE OBTAINED BY ELECTRODES ON ENDOTRACHEAL TUBE (ET) AND THYROID CARTILAGE (TC). THIS STUDY ANALYZED 205 RECURRENT LARYNGEAL NERVES (RLNS) AT RISK IN 110 PATIENTS UNDERGOING MONITORED THYROIDECTOMY (13 UNILATERAL TOTAL LOBECTOMIES AND 97 TOTAL THYROIDECTOMIES). ALL PROCEDURES WERE PERFORMED BY THE SAME SURGEON IN 110 PATIENTS FROM JANUARY TO DECEMBER, 2016. SUBSTANTIAL AMPLITUDE DECREASES (DEFINED AS >50%) OCCURRED IN 20 NERVES MONITORED BY ET ELECTRODES, BUT IN NONE OF THE NERVES MONITORED BY TC ELECTRODES. NOTABLY, FALSE LOS (EMG <(><<)> 100 MV) EVENTS OCCURRED IN 3 OF THE 20 NERVES WITH SUBSTANTIAL AMPLITUDE DECREASE MONITORED BY ET ELECTRODES. ALL FALSE LOS EVENTS RESULTED FROM ET DISPLACEMENT DURING THE SURGICAL MANIPULATION. IN THREE NERVES THAT SHOWED SUBSTANTIAL AMPLITUDE DECREASES INTRAOPERATIVELY, THE EMG AMPLITUDE GRADUALLY RECOVERED TO BASELINE AFTER RELEASE OF THYROID TRACTION. AFTER RLN DISSECTION, A WEAK OR DISRUPTED POINT OF NERVE CONDUCTION WAS DETECTED AT THE REGION OF LIGAMENT OF BERRY (LOB) IN 9 NERVES. AMONG THESE 9 NERVES, 7 NERVES WITH PARTIAL LOS ALL SHOWED FREE POSTOPERATIVE VOCAL CORD MOBILITY; THE REMAINING 2 NERVES WITH COMPLETE LOS BEFORE WOUND CLOSURE DEVELOPED TEMPORARY VOCAL PALSY POSTOPERATIVELY. NEITHER PERMANENT RLN PALSY, NOR COMPLICATIONS FROM THE USE ET OR TC ELECTRODES WERE OBSERVED IN THIS STUDY. OVERALL, THE EMG SIGNALS DETECTED BY TC ELECTRODES WERE MORE STABLE THAN THOSE DETECTED BY ET ELECTRODES. IN THE NINE NERVE INJURIES CAUSED BY TRACTION STRESS AT THE REGION OF LOB, THE TWO ELECTRODE TYPES RELIABLY RECORDED SIMILAR EMG AMPLITUDE REDUCTIONS. ONE MALE PATIENT IN THIS STUDY REQUIRED A SMALLER SIZE 6.0 EMG TUBE AFTER A FAILED INTUBATION WITH A SIZE 7.0 EMG TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575720 NIM® CAPITAL ACCESSORY STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. XOM UNK NIM ACC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1