BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3642285 · Received February 24, 2014

    Report

    Report Number
    1045254-2014-00044
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: 8229706, EMG TUBE 8229706 NIM TRIVANTAGE 6.0MM ID, LOT: 0207751453, MANUFACTURED: NOVEMBER 21, 2013 USE BEFORE: NOVEMBER 20, 2017, 510K: K112686, ETN. (B)(4). PRODUCT EVALUATION: NO ANALYSIS AVAILABLE; DEVICES NOT RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED.

    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 THE NIM WAS MAKING ODD NOISES THAT WEREN¿T ¿USUAL¿ TO WHAT THE SURGEON USUALLY HEARS, ALTHOUGH HE HASN¿T DONE MANY CASES WITH IT, AND THE SURGEON HAD TO ABANDON THE CASE AFTER TAKING ONE SIDE OF THE THYROID OUT BECAUSE HE WASN¿T QUITE SURE WHAT WAS HAPPENING; ANOTHER PROCEDURE WILL NEED TO BE DONE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113188 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 65063300

    Patients

    Seq Age Sex Outcome Treatment
    1