BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG ELECTRODE

    MDR report key: 6326517 · Received February 13, 2017

    Report

    Report Number
    1045254-2017-00056
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 16, 2017
    Report Date
    January 18, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GXZ
    PMA / PMN Number
    K002992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 8225101 ¿ PROBE, 5PK STD PRASS FLUSH TIP; LOT NUMBER ¿ 0211358452; MANUFACTURE DATE ¿ JUNE 1, 2016; USED BY DATE ¿ MAY 30, 2024; UDI ¿ (B)(4); 510K NUMBER - K934426. THE DEVICE HAS BEEN RECEIVED BY MEDTRONIC. THE PRODUCT ANALYSIS HAS NOT YET BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). (PAIRED 4-CHANNEL SET ELECTRODES): THE PRODUCT ANALYSIS INDICATES THAT ONE UNSEALED SAMPLE WAS RECEIVED. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE(S) THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PAIRED SUBDERMAL ELECTRODES SHALL EXHIBIT CONTINUITY FROM NEEDLE TIP TO CONNECTING PIN WITH A MEASUREMENT LESS THAN 2.0OHMS [AND SHALL EXHIBIT INFINITY BETWEEN NEEDLES AND CONNECTORS]. THE BLUE PAIRED MEASURED 1.7OHMS / 1.7OHMS, THE RED PAIRED MEASURED 1.6OHMS / 1.6OHMS, THE PURPLE PAIRED MEASURED 1.7OHMS / 1.7OHMS, AND THE ORANGE PAIRED MEASURED 1.6OHMS / 1.6OHMS. ALL ELECTRODES WERE INFINITE BETWEEN POLES AND NO OUT OF SPECIFICATION CONDITION WAS IDENTIFIED. THE RED/WHITE AND GREEN ELECTRODES END TO END OHMS RESISTANCE SHALL BE LESS THAN 2.5 OHMS. THE ACTUAL MEASUREMENTS FOR THE RED/WHITE WAS 0.8 OHMS. THE ACTUAL MEASUREMENTS FOR THE GREEN WAS 0.8 OHMS, INDICATING AN IN SPECIFICATION CONDITION. THIS IS A SUPPLIED MATERIAL ASSEMBLY WITH NO OUT OF SPECIFICATION CONDITION, THEREFORE MANUFACTURING AND SUPPLIER HAVE BEEN RULED OUT AS LIKELY CAUSES. (B)(4) (STD PRASS FLUSH TIP PROBE): THE PRODUCT ANALYSIS INDICATES THAT ONE UNSEALED SAMPLE WAS RECEIVED. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP FIT SECURELY IN THE HANDLE. THE PROBE WAS PLUGGED INTO A NIM SYSTEM USING 1.0 MA STIMULATING CURRENT AND 100UV THRESHOLD. WHEN STIMULATING, THE SYSTEM RETURNED 1.02 MA AND A WAVEFORM / TONE OVER 200UV. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND NO MALFUNCTION FOUND AS IT RELATES TO THE COMPLAINT, THEREFORE MANUFACTURING AND SUPPLIER ISSUES HAVE BEEN RULED OUT AS LIKELY CAUSES.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PAROTIDECTOMY, THE ELECTRODE AND PROBE COULD NOT DETECT NERVES. THERE WAS NO SURGERY DELAY. THE PATIENT¿S NERVES FUNCTIONED WELL AFTER SURGERY.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION INDICATES THAT THE USER SAW A FLAT LINE ON THE SCREEN AND HEARD NO SOUND FROM THE SYSTEM. THE STIMULATOR WAS SET AT 3.0 AND THE STIM RETURN VALUE WAS ZERO. THE SYSTEM WAS RECOGNIZING THE ELECTRODES, BUT NOT DETECTING THE NERVE. IT WAS THE INITIAL USE OF THE ELECTRODES AND PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107939 NIM® EMG ELECTRODE ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED INC. 8227411 0210846275

    Patients

    Seq Age Sex Outcome Treatment
    1