BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6766657 · Received August 4, 2017

    Report

    Report Number
    1045254-2017-00267
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Report Date
    July 11, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00613994499615
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: 8253001: NIM MAINFRAME RESPONSE 3.0, SERIAL # (B)(4), LOT # 205993187, MANUFACTURED DATE ¿ JUN/27/2012, 510(K) # K083124, (B)(4). THE NIM PATIENT INTERFACE (PRODUCT # 8253200) WAS RETURNED FOR ANALYSIS. EVALUATION CONFIRMED THE REPORTED OF NOT WORKING CONSISTENTLY. ANALYSIS FOUND THAT THE P/I PCB FAILED, THE CABLE FAILED THE TRIBOELECTRIC IMMUNITY TEST AND THE CABLE CLIPS ARE BROKEN. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE NIM MAINFRAME RESPONSE (PRODUCT # 8253001) WAS RETURNED FOR ANALYSIS. EVALUATION FOUND THAT THE UNIT CAME IN WITH A SCRATCHED TOUCH SCREEN AND INTERMITTENT SOFTWARE FAILURE. THE DEVICE HAD A FAILED CPU PCB. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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 REPORTED THAT NIM SYSTEM WAS NOT WORKING CONSISTENTLY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546698 NIM® 3.0 INTERFACE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253200 205985036 00613994499615

    Patients

    Seq Age Sex Outcome Treatment
    1