BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3802438 · Received May 9, 2014

    Report

    Report Number
    1045254-2014-00106
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: MAINFRAME: 8253001, NIM RESPONSE 3.0 , 510K: K083124, SERIAL # (B)(4), LOT# 63821700, MANUFACTURE DATE: 2009-09-17 (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 THE NIMS WERE ''NOT WORKING'' DURING A PROCEDURE. THERE WAS NO OTHER INFORMATION AVAILABLE ABOUT THE EVENT. THE CLINICAL ENGINEER "TESTED BOTH NIM3.0 SYSTEMS WITH THE SIMULATOR BOX AND PASSED THE ELECTRODES CHECK AND ABLE TO STIMULATE WITHOUT ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281576 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 63787500

    Patients

    Seq Age Sex Outcome Treatment
    1