BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6876709 · Received September 19, 2017

    Report

    Report Number
    1045254-2017-00325
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Report Date
    August 24, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00613994499615
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES:(B)(4) NIM MAINFRAME RESPONSE 3.0, SERIAL # (B)(4), LOT # 207857253, MANUFACTURED DATE ¿ DEC/20/2013, 510(K) # K083124, UDI #(B)(4). THE NIM PATIENT INTERFACE 3.0 (PRODUCT # 8253200) WAS RETURNED FOR ANALYSIS. EVALUATION COULD NOT DUPLICATE THE REPORTED EVENT OF WORKING INTERMITTENTLY. THERE WAS NO FAULT FOUND WITH THE DEVICE. THE DEVICE WAS CLEANED, TESTED TO ALL MANUFACTURING PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE NIM MAINFRAME RESPONSE 3.0 (PRODUCT # 8253001) WAS RETURNED FOR ANALYSIS. EVALUATION COULD NOT DUPLICATE THE REPORTED EVENT OF WORKING INTERMITTENTLY. THERE WAS NO FAULT FOUND WITH THE DEVICE. THE DEVICE WAS CLEANED, TESTED TO ALL MANUFACTURING PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT PRE-OPERATIVE THE DEVICE WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656678 NIM® 3.0 INTERFACE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253200 207851623 00613994499615

    Patients

    Seq Age Sex Outcome Treatment
    1