BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 6200593 · Received December 22, 2016

    Report

    Report Number
    1045254-2016-00435
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169230392
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: (B)(4). NOTE: THE PATIENT INTERFACE 8253200, S/N (B)(4), WAS NOT RECEIVED FOR EVALUATION. THIS DEVICE WAS NOT RETURNED, NO ANALYSIS WAS PERFORMED. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: 8253200 - PATIENT INTERFACE 8253200 RESPONSE 3.0, S/N (B)(4), LOT 211629684, MANUFACTURED: 07/18/2016. PRODUCT EVALUATION: UPON EVALUATION OF THE MAINFRAME (8253002), SERVICE AND REPAIR FOUND THAT THE DEVICE WAS RECEIVED IN GOOD CONDITION. - DURING PRETEST NO ISSUES ON DEVICE; OPENED ALL POSSIBLE CONNECTIONS, CHECKED NO DEVIATIONS FOUND. A 48 HOUR BURN HAS BEEN PERFORMED TO TRY TO FIND THE COMPLAINT; NO RESULTS, DEVICE WORKING ACCORDING TO SPECS. TOUCHSCREEN CALIBRATION HAS BEEN PERFORMED. EVALUATION OF PATIENT INTERFACE 8253200 IS ANTICIPATED BUT NOT YET BEGUN. 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

    THE NIM COULD NOT BE SET UP AS THE ELECTRODE CHECK WASN'T SUCCESSFUL DESPITE ANESTHETIZED WITHOUT ANY PARALYTIC AGENT OR THE CHARGEABLE TABLE BEING PLUGGED IN. THE DISPLAY WAS "FLASHING ERRONEOUS MESSAGES". THE PATIENT DID NOT HAVE THE PROCEDURE DONE BECAUSE THE NIM DID NOT WORK; THE CASE WAS CANCELLED. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848841 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 211599496 00643169230392

    Patients

    Seq Age Sex Outcome Treatment
    1 Other