BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG ELECTRODE

    MDR report key: 6942079 · Received October 11, 2017

    Report

    Report Number
    1045254-2017-00360
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    IKT
    UDI-DI
    00643169290006
    PMA / PMN Number
    K002992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE ELECTRODES WERE RECEIVED FOR ANALYSIS. THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE ELECTRODES THAT WOULD RESULT IN THE REPORTED EVENT. THE END TO END RESISTANCE FOR EACH SIDE OF THE PAIRED ELECTRODES SHALL BE <(><<)>2.0 OHMS AND INFINITE OHMS BETWEEN NEEDLE TIPS [NO SHORT CIRCUIT]. THE ACTUAL MEASUREMENTS OF THE RED PAIRED WERE AS FOLLOWS - ONE POLE MEASURED 1.7 OHMS AND THE OTHER 1.8 OHMS WITH NO SHORT CIRCUIT BETWEEN POLES (IN SPECIFICATION). THE ACTUAL MEASUREMENT OF THE BLUE PAIRED WERE AS FOLLOWS - BOTH POLES MEASURED 1.7 OHMS WITH NO SHORT CIRCUIT BETWEEN POLES (IN SPECIFICATION). THE RED/WHITE AND GREEN END TO END OHMS RESISTANCE SHALL BE LESS THAN 2.5 OHMS; THE ACTUAL MEASUREMENTS FOR THE RED/WHITE WAS 0.9 OHMS; THE ACTUAL MEASUREMENTS FOR THE GREEN WAS 0.9 OHMS (BOTH WERE IN SPECIFICATION). THE INFORMATION MOST LIKELY INDICATES A FAILURE TO ADHERE TO THE IFU WARNINGS. ** THE INSTRUCTIONS FOR USE WARNS: TO AVOID ALTERNATE SITE PATIENT BURNS OR LESIONS: ¿ A. DO NOT ACTIVATE THE ELECTROSURGICAL INSTRUMENTS (ESU) WHILE STIMULATOR IS IN CONTACT WITH TISSUE. ¿ B. DO NOT LEAVE STIMULATING ELECTRODES OR PROBES IN SURGICAL FIELD. ¿ C. DO NOT STORE STIMULATING ELECTRODES OR PROBES IN ELECTROSURGICAL INSTRUMENT HOLDER. ¿ D. DO NOT ALLOW A SECOND SURGEON (FOR EXAMPLE, FAT HARVESTING) TO USE ELECTROSURGICAL INSTRUMENTS WHILE STIMULATOR IS IN USE. ¿ E. DO NOT ACTIVATE ELECTROSURGICAL INSTRUMENT FOR PROLONGED PERIODS WHILE ESU IS NOT IN CONTACT WITH TISSUE. ¿ F. DO NOT ACTIVATE ELECTROSURGICAL INSTRUMENT NEAR THE RECORDING OR STIMULATING ELECTRODES. ¿ G. DO NOT ALLOW PATIENT INTERFACE BOXES OR RECORDING / STIMULATING ELECTRODES SITES TO BE FLOODED WITH SALINE. ¿ H. DO NOT ALLOW EXCESSIVE STRAY AC OR DC LEAKAGE CURRENTS FROM PATIENT CONNECTED EQUIPMENT; AVOID CREATING AN UNINTENDED GROUNDING PATH THROUGH APPLIED ELECTRODES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT WHEN SETTING UP FOR A COCHLEAR IMPLANT THE SKIN WHERE THE NIM ELECTRODES WOULD BE APPLIED WAS DISINFECTED USING THEIR ¿NORMAL PROCEDURE¿. FOLLOWING THE PROCEDURE IT WAS NOTED THAT A ¿BURN WOUND OCCURRED BETWEEN THE GROUND CORD AND STIM RETURN CORD LOCATED: WIDTH - 1 CM AND DEPTH - 0.1 CM - 0.3 CM (ONE SIDE TO THE OTHER SIDE).¿ THE PHYSICIAN REMOVED THE ¿BURN PARTS AND STITCHED THE WOUND.¿ FOLLOWING THE PROCEDURE, THE GROUND CORD AND STIM RETURN CORD WERE TESTED; BOTH ¿ACTED NORMALLY¿. IT WAS CONFIRMED THAT DURING THE PROCEDURE A ¿BI-POLAR CONMED¿ WAS USED AND THE CABLES OF THE ¿BI-POLAR CONMED¿ AND THE ELECTRODES WERE SIDE BY SIDE. AT THIS TIME, THE PATIENT¿S SKIN IS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721367 NIM® EMG ELECTRODE ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH IKT MEDTRONIC XOMED INC. 8227410 0212244318 00643169290006

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR