BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISATRACE ECG ELECTRODE

    MDR report key: 484628 · Received September 19, 2003

    Report

    Report Number
    1317214-2003-00051
    Event Type
    Other
    Date Received
    September 19, 2003
    Date of Event
    August 20, 2003
    Report Date
    August 25, 2003
    Manufacturer
    CONMED CORP.
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING AN MRI PROCEDURE OF THE SPINE, LASTING APPROX. 30 MINUTES, THE PATIENT WAS ANESTHETIZED. THEY RECEIVED BURNS UNDER THE 3 ECG ELECTRODES ON THEIR CHEST. THE SEVERITY OF BURNS WAS NOT REPORTED. NO MEDICAL TREATMENT OR INTERVENTION WAS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISATRACE ECG ELECTRODE EGG MONITORING ELECTRODES DRX CONMED CORP. NA 0203041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other TESLA PLUS EDTES 03D, 2003.| MAGNETOM IMPACT EXPERT 2003.