BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOBLATE ABLATION PEN

    MDR report key: 466778 · Received June 17, 2003

    Report

    Report Number
    2135394-2003-00002
    Event Type
    Injury
    Date Received
    June 17, 2003
    Date of Event
    May 21, 2003
    Report Date
    May 21, 2003
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    ---
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION REVIEWED INDICATES THE PATIENT INCURRED A BURN DURING AN ABLATION PROCEDURE. UPON COMPLETION OF THE CASE, BLISTERS WERE NOTED IN AN AREA OF THE PATIENT'S SKIN LOCATED ON THEIR BACK. HCP LATER INDICATED INCORRECT DISPERSION ELECTRODE POSITIONING OCCURRED PRIOR TO THE EVENT. NO ADDITIONAL PATIENT CONSEQUENCE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOBLATE ABLATION PEN ABLATION PEN AND ELECTRODE --- MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 60816 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention