BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG

    MDR report key: 6400550 · Received March 13, 2017

    Report

    Report Number
    1045254-2017-00084
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Report Date
    February 15, 2017
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: XOM UNKNOWN NIM (NIM 3.0): PRODUCT NUMBER ¿ UNKNOWN; SERIAL NUMBER ¿ UNKNOWN; LOT NUMBER ¿ UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN; UDI NUMBER ¿ UNKNOWN; 510K NUMBER ¿ UNKNOWN XOM UNK NIM ACC (NIM ACCESSORY ¿ PRASS SLIM MONOPOLAR SIMULATOR PROBE): PRODUCT NUMBER ¿ UNKNOWN; LOT NUMBER ¿ UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN; USE BY DATE ¿ UNKNOWN; UDI NUMBER ¿ UNKNOWN; 510K NUMBER ¿ UNKNOWN. THE DEVICES ARE BEING REPORTED FROM A LITERATURE ARTICLE. NO DEVICES HAVE BEEN RETURNED. NO PRODUCT ANALYSES HAVE BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE OCCURRENCE OF FALSE NEGATIVES IN SEVERAL CASES WERE REFERENCED IN THE RETROSPECTIVE CASE STUDY ARTICLE PUBLISHED IN, ¿THE LARYNGOSCOPE¿ [LARYNGOSCOPE, 00:000-000, 2016] TITLED ¿CHANGES IN ELECTROMYOGRAPHIC AMPLITUDES BUT NOT LATENCIES OCCUR WITH ENDOTRACHEAL TUBE MALPOSITIONING DURING INTRAOPERATIVE MONITORING FOR THYROID SURGERY: IMPLICATIONS FOR GUIDELINES¿ BY SAMUEL R. BARBER, MS AND SEVERAL OTHER CONTRIBUTORS. THE ARTICLE DISCUSSES INTRAOPERATIVE NEURAL MONITORING (IONM) IN THYROID AND PARATHYROID SURGERY, ENDOTRACHEAL (ET) TUBE MIGRATION CAN RESULT IN A DECREASE IN VOCALIS ELECTROMYOGRAPHIC (EMG) AMPLITUDE WITHOUT A CONCORDANT LATENCY ELEVATION DURING STIMULATION OF THE RECURRENT LARYNGEAL NERVE (RLN). THERE WERE NO UNIQUE CASE, PATIENT, OR DEVICE IDENTIFIERS (NO MODEL, SERIAL, OR LOT NUMBERS) REFERENCED IN THE ARTICLE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182645 NIM® EMG STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. XOM UNKNOWN EMG

    Patients

    Seq Age Sex Outcome Treatment
    1