BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM RESPONSE® NERVE MONITORING SYSTEM

    MDR report key: 4040027 · Received August 27, 2014

    Report

    Report Number
    1045254-2014-00206
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253200 - PATIENT INTERFACE, RESPONSE 3.0; MANUFACTURE DATE ¿ MARCH 29, 2010; SERIAL NUMBER ¿ (B)(4); LOT NUMBER ¿ 66888400; 510K CLEARANCE - K083124. (B)(4). THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, AN ANALYSIS OF THE DEVICE CANNOT BE PERFORMED. METHOD: NO TESTING METHODS PERFORMED. (B)(4). BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDTRONIC SALES REP THAT A PATIENT SUFFERED LARYNGEAL NERVE PARALYSIS DURING A THYROID PROCEDURE IN WHICH THE NIM 3.0 SYSTEM WAS BEING USED. THE CUSTOMER HAS NOT ALLEGED ANY MALFUNCTION OR FAILURE OF THE DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT WITH NO RESPONSE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520597 NIM RESPONSE® NERVE MONITORING SYSTEM STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 64541400

    Patients

    Seq Age Sex Outcome Treatment
    1