BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253002 NIM RESPONSE 3.0 INTL

    MDR report key: 3629556 · Received February 14, 2014

    Report

    Report Number
    1045254-2014-00033
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE IS STILL IN USE AND WILL NOT BE RETURNED. 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 DURING A PAROTID CASE THERE WAS AN ISSUE WITH THE DEVICE NOT WORKING PROPERLY. IT WAS NOTED THAT THERE WAS "NO SIGNAL" WHICH MAY INDICATE THE SYSTEM WAS NOT RESPONDING TO STIMULATION OR THERE WAS NO STIMULATION BEING DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY. FURTHER DETAILS WERE REQUESTED BUT NO INFORMATION WAS AVAILABLE BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98605 MAINFRAME 8253002 NIM RESPONSE 3.0 INTL STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8253002 72097800

    Patients

    Seq Age Sex Outcome Treatment
    1