BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 4414595 · Received January 13, 2015

    Report

    Report Number
    1045254-2015-00013
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    December 10, 2014
    Report Date
    December 11, 2014
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED 2015-01-06. DEVICE EVALUATED BY ENGINEERING 2015-02-09. THE PRODUCT ANALYSIS FOR 8253001 (NIM RESPONSE 3.0 MAINFRAME) FOUND NO FAULT WITH THE DEVICE. AS A PRECAUTIONARY MEASURE, THE TOUCHSCREEN WAS CALIBRATED AND THE DEVICE WAS PLACED IN THE BURN-IN UNIT FOR 24 HOURS, ATTEMPTING TO OBSERVE HEAT-RELATED FAILURES. THE UNIT NEVER FAILED, AND WHEN TESTED PASSED ALL MANUFACTURING SPECIFICATIONS. THE PRODUCT ANALYSIS FOR 8253200 (PATIENT INTERFACE) FOUND NO FAULT WITH THE DEVICE. IT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. METHOD: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION; TEMPERATURE TESTING; SIMULATED USE TESTING. RESULTS: NO FAILURE DETECTED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT.

    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, "WE WERE 75% THROUGH THE CASE WHEN THE ENTIRE MACHINE WENT TOTALLY SILENT AND THE SCREEN FROZE. WE STOPPED THE SURGERY [FOR 1 HOUR] AND TRIED TO RELOAD THE SETTINGS AND THEN EVEN REBOOTED IT. THE MACHINE THEN SORT OF WORKED BUT THE PRASS PROBE WAS LESS USEFUL AND THE MACHINE WAS NOT MAKING THE SAME SORTS OF NORMAL SOUNDS WE HAD PRIOR TO THE ¿SEIZURE¿. " THE NURSE SENT ADDITIONAL INFORMATION INDICATING THAT THERE WAS A PATIENT NERVE INJURY REQUIRING ADDITIONAL INTERVENTION (VOCAL CORD INJECTION). THE PROCEDURE WAS A TOTAL THYROIDECTOMY LASTING APPROXIMATELY 6.5 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30836 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC 8253001 208538306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention