BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6839468 · Received September 1, 2017

    Report

    Report Number
    1045254-2017-00303
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 4, 2017
    Report Date
    October 23, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169283275
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NIM PATIENT INTERFACE (PRODUCT # 8253200) HAS BEEN COMPLETED. EVALUATION COULD NOT DUPLICATE THE REPORTED EVENT OF FAILURE DURING SURGERY. EVALUATION FOUND NO FUNCTIONAL FAULT WITH THE DEVICE. THE DEVICE WAS 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 OF FAILURE DURING SURGERY. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253002 - NIM MAINFRAME RESPONSE 3.0, SERIAL # (B)(4), LOT # 6435200, MANUFACTURED DATE ¿ FEB/26/2010, 510(K) # K083124, (B)(4). THE DEVICES WERE RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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.

    Description of Event or Problem · 1

    THE FACILITY ALLEGED A DEFECT WITH THE NIM SYSTEM DURING A THYROID SURGERY. THERE WAS NO REPORT OF PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FOR THIS REPORTED EVENT HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617270 NIM® 3.0 INTERFACE STIMULATOR, NERVE GWF MEDTRONIC XOMED INC. 8253200 211695588 00643169283275

    Patients

    Seq Age Sex Outcome Treatment
    1