BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 6562136 · Received May 11, 2017

    Report

    Report Number
    1045254-2017-00148
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 18, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169230385
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 8253200: NIM PATIENT INTERFACE RESPONSE 3.0, SERIAL # (B)(4), LOT # 209903068, MANUFACTURED DATE ¿ JUL/23/2015, 510(K) # K083124, UDI # (B)(4). THE NIM MAINFRAME (PRODUCT # 8253001) AND THE NIM PATIENT INTERFACE (PRODUCT # 8253200) WERE RETURNED FOR EVALUATION. EVALUATION OF THE NIM MAINFRAME (PRODUCT # 8253001) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF NOT WORKING PROPERLY. EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF PATIENT INTERFACE (PRODUCT # 8253200) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF NOT WORKING PROPERLY. EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE 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

    IT WAS REPORTED THAT PRE-OPERATIVE THE NIM SYSTEM WAS NOT WORKING PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342771 NIM® 3.0 MAINFRAME STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253001 210024820 00643169230385

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10