BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6897680 · Received September 27, 2017

    Report

    Report Number
    1045254-2017-00334
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Report Date
    October 25, 2017
    Manufacturer
    MEDTRONIC XOMED INC
    Product Code
    GWF
    UDI-DI
    00613994499615
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253002: NIM MAINFRAME RESPONSE 3.0, SERIAL # (B)(4), LOT # 66057100, MANUFACTURED DATE: FEB/05/2010, 510(K) # K083124, UDI # (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NIM PATIENT INTERFACE (PRODUCT # 8253200) HAS BEEN COMPLETED. EVALUATION INDICATED THAT THE REPORTED EVENT: ¿NOT PICKING UP NERVE RESPONSE,¿ WAS PARTIALLY CONFIRMED. ANALYSIS FOUND THAT STIM 1 DOES NOT WORK. THE FUSE ON STIM 1 WAS WORN. ASSEMBLY CLIPS WERE LOOSE AND THE WAVE WASHERS WERE WORN ON THE DEVICE. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. ANALYSIS OF THE NIM MAINFRAME RESPONSE (PRODUCT # 8253002) HAS BEEN COMPLETED. EVALUATION COULD NOT DUPLICATE THE REPORTED EVENT: ¿NOT PICKING UP NERVE RESPONSE.¿ EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE WAS TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE NIM SYSTEM IS NOT PICKING UP NERVE RESPONSE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678154 NIM® 3.0 INTERFACE STIMULATOR, NERVE GWF MEDTRONIC XOMED INC 8253200 64502000 00613994499615

    Patients

    Seq Age Sex Outcome Treatment
    1