BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM PRASS PAIRED ELECTRODES

    MDR report key: 4266744 · Received November 20, 2014

    Report

    Report Number
    1045254-2014-00300
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GXZ
    PMA / PMN Number
    K002992
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. MAINFRAME (B)(4) NIM NEURO 3.0 INTL, 510K: K083124, SERIAL # (B)(4), LOT# 6681500, MANUFACTURED 2010-(B)(6). THE PRODUCT ANALYSIS CANNOT BE COMPLETED ON THE ELECTRODE (B)(4) 5SET PRASS PAIRED 25MM, AS THE ELECTRODES WERE DISCARDED. THE MAINFRAME (B)(4) NIM NEURO 3.0 INTL HAS NOT BEEN RETURNED AT THIS TIME. (B)(4)

    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 SYSTEM WAS NOT TESTED PRIOR TO BEGINNING ITS USE IN A PAROTIDECTOMY. THE MACHINE WAS WORKING INTERMITTENTLY WHICH WAS EVIDENT DUE TO THE GREEN ¿TICK MARKS¿ INTERMITTENTLY TURNING OFF AND THE SURGEON CONTINUE THE CASE WITH THE NIM NOT WORKING. POST OPERATIVELY A PATIENT HAD RIGHT-SIDED FACIAL PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755172 NIM PRASS PAIRED ELECTRODES ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED INC. 8227301

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention