BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® PROBE

    MDR report key: 7366739 · Received March 23, 2018

    Report

    Report Number
    1045254-2018-00125
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    20613994430209
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8229708, UDI#: (B)(4) AND 510K: K112686. NO PRODUCT ANALYSIS. THE REPORTED PRODUCTS ARE BEING SHIPPED FROM (B)(6) TO THE US FACILITY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF ONE OPENED SAMPLE PRODUCT NUMBER 8225490 FROM LOT NUMBER [NO INFORMATION], HAS BEEN COMPLETED. EVALUATION INDICATED 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 STIMULATING PLUG / WIRE TO TIP SHOWED CONTINUITY WITH A READING OF 0.3 OHMS. 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 300UV. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING, NO MALFUNCTION FOUND AND NO OUT OF SPECIFICATION CONDITION IDENTIFIED AS IT RELATES TO THE COMPLAINT. ANALYSIS OF ONE OPENED SAMPLE PRODUCT NUMBER 8229708 FROM LOT NUMBER 0212919339, HAS BEEN COMPLETED. EVALUATION INDICATED NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. ELECTRICALLY, THE RESISTANCE OF THE ELECTRODES FROM END TO END SHALL BE LESS THAN 200 OHMS AND THE ACTUAL MEASUREMENTS WERE; RED 10 OHMS, RED [W/WHITE BAND] 14 OHMS, BLUE 13 OHMS, AND BLUE [W/WHITE BAND] 9 OHMS. THERE WERE NO SHORTS BETWEEN CIRCUITS OR INTERMITTENT BEHAVIOR WHILE MANIPULATING THE CIRCUITS. WHEN VIEWED UNDER MAGNIFICATION, THERE WERE NO CRACKS IN THE ELECTRODE CONTACTS. THE RED / WHITE AND GREEN END TO END OHMS RESISTANCE SHALL BE LESS THAN 2.5 OHMS; THE ACTUAL MEASUREMENTS WERE 2.0 OHMS AND 1.9 OHMS RESPECTIVELY, WHICH IS IN SPECIFICATION. THERE WAS NO FAULT FOUND, NO EVIDENCE OF IMPROPER MANUFACTURING AND NO OUT OF SPECIFICATION CONDITION IDENTIFIED AS IT RELATES TO THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE SITE PHYSICIAN (UNKNOWN) REPORTED A FIBER THAT WAS THOUGHT TO BE A NERVE WAS STIMULATED, BUT THERE WAS NO RESPONSE. NO PATIENT IMPACT OR INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING THE EMG TUBE AND PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208723 NIM® PROBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8225490 20613994430209

    Patients

    Seq Age Sex Outcome Treatment
    1