BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6230606 · Received January 6, 2017

    Report

    Report Number
    1045254-2017-00012
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 7, 2016
    Report Date
    December 14, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994499615
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): MAINFRAME NIM RESPONSE 3.0, SERIAL # (B)(4), LOT # 207960814, MANUFACTURED DATE -JAN/24/2014, 510(K) # K083124, (B)(4). THE NIM PATIENT INTERFACE (PRODUCT # 8253200) WAS AND THE NIM MAINFRAME (PRODUCT # 8253001) WERE RETURNED FOR EVALUATION. EVALUATION OF PATIENT INTERFACE (PRODUCT # 8253200) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF ¿NERVE NOT DETECTED BY THE DEVICE.¿ THE WAVE WASHER WAS REPLACED DUE TO A LOOSE CLIP. THERE WAS NO FUNCTIONAL FAULT FOUND WITH THE DEVICE. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF THE NIM MAINFRAME (PRODUCT # 8253001) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF ¿NERVE NOT DETECTED BY THE DEVICE.¿ AS A PRECAUTIONARY MEASURE THE DEVICE WAS PLACED IN THE BURN IN FOR 24 HOURS ATTEMPTING TO OBSERVE ANY HEAT FAILURES. THE DEVICE DID NOT FAIL. EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OPERATIVE THE NIM SYSTEM WOULD STIMULATE THE NERVE, THEN WOULDN'T STIMULATE THE NERVE BUT WOULD STIMULATE EVERYTHING THAT IT TOUCHED, INCLUDING TRACHEA AND ESOPHAGUS. NERVE WAS IDENTIFIED BUT WAS NOT DETECTED BY THE DEVICE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12136 NIM® 3.0 INTERFACE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253200 208003662 00613994499615

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR