BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE 8227410 PAIRED 2 CHANNEL SET

    MDR report key: 3053052 · Received April 11, 2013

    Report

    Report Number
    1045254-2013-00324
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    IKT
    PMA / PMN Number
    K002992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (B)(4) 2013 INDICATED THAT THE EVENT OCCURRED DURING A PAROTID PROCEDURE. THERE WERE NO ALARMS OR ALERTS DISPLAYED, BUT THE ACCOUNT COULD NOT OBTAIN A WAVEFORM ON THE MONITOR AT ALL. THE ACCOUNT TRIED SWITCHING THE LEADS. IT SHOULD BE NOTED THAT THE MONITOR HAD JUST RETURNED FROM VENDOR EVALUATION AND WAS REPORTED TO FUNCTION NORMALLY. THE ELECTRODES WERE DISPOSED OF BY THE ACCOUNT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4): PRODUCT HAS NOT BEEN RETURNED. METHOD - NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    CORRECTION: CONCOMITANT DEVICE: MEDTRONIC MONITOR (UNKNOWN ID, LOT) COULD HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT.

    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 TWO ELECTRODES FAILED DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON A (B)(6) FEMALE, TWO ELECTRODES FAILED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013 INDICATED THAT THE EVENT OCCURRED DURING A PAROTID PROCEDURE. THERE WERE NO ALARMS OR ALERTS DISPLAYED, BUT THE ACCOUNT COULD NOT OBTAIN A WAVEFORM ON THE MONITOR AT ALL. THE ACCOUNT TRIED SWITCHING THE LEADS. IT SHOULD BE NOTED THAT THE MONITOR HAD JUST RETURNED FROM VENDOR EVALUATION AND WAS REPORTED TO FUNCTION NORMALLY. THE ELECTRODES WERE DISPOSED OF BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156734 ELECTRODE 8227410 PAIRED 2 CHANNEL SET ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH IKT MEDTRONIC XOMED, INC. 8227410 0206471830

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR MONITOR