BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENT EMG/LASER P/N UNKNOWN

    MDR report key: 3211202 · Received July 8, 2013

    Report

    Report Number
    1045254-2013-00444
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, NO DEVICES WERE RECEIVED 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 A MEDTRONIC EMG TUBE WAS SUSPECTED TO BE BROKEN. THIS WAS THE ONLY INFORMATION OBTAINED AND THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309718 ENT EMG/LASER P/N UNKNOWN STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. XOM UNKNOWN EMG NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1