BEUDAMED
    FDA Adverse Event Other Summary report: N

    3003768277-2008-00018

    MDR report key: 1080711 · Received July 9, 2008

    Report

    Report Number
    3003768277-2008-00018
    Event Type
    Other
    Date Received
    July 9, 2008
    Product Code
    LNH
    PMA / PMN Number
    k052013
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS)- CODE (OTHER)- THE RF BURN WAS MOST LIKELY CAUSE BY UNWANTED RF INTERFERENCE. THE INTERNAL SHIELDING OF THE COIL MAY BE ALSO DAMAGED, DEPENDING OF THE POSITION OF THE COIL AND THE PT THIS COULD LEAD TO HEATING OF THE COIL ELEMENTS CAUSING THE RF BURN. THIS IS NO PROBLEM IN CASE ISOLATING MATERIAL IS USED, BUT MAY LEAD TO BURNS IN CASE THE COIL IS USED WITHOUT PROTECTION. THESE KIND OF INCIDENTS CAN BE PREVENTED AS MUCH AS POSSIBLE, BY FOLLOWING THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LNH

    Patients

    Seq Age Sex Outcome Treatment
    1