BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENERAL ELECTRIC

    MDR report key: 25416 · Received January 6, 1995

    Report

    Report Number
    25416
    Event Type
    Other
    Date Received
    January 6, 1995
    Date of Event
    August 30, 1994
    Report Date
    November 7, 1994
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    GXD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STATUS POST RAIOFREQUENCY CARDIAC CATHETER. ABLATION PERFORMED ON 8/30/94, DEVELOPED A SKIN CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC FLUOROSCOPY GENERATOR UNIT GXD GENERAL ELECTRIC MEDICAL SYSTEMS MPX AP-46-182799PP15

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other SEE ATTACHED.