BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 2841528 · Received November 21, 2012

    Report

    Report Number
    1045254-2012-00683
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    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 DURING A PROCEDURE, THE SURGEON WAS "ON THE NERVE AND HE COULD CLEARLY SEE IT BUT THE MONITOR DIDN'T GIVE ANY RESPONSE OR STIMULATION." THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. THE SYSTEM WAS TESTED AT THE USER FACILITY AFTER THE INCIDENT AND NO FAULT WAS FOUND WITH THE SYSTEM. THE SYSTEM CONTINUES TO BE USED BY THE USER FACILITY AND NO FURTHER INCIDENTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1