BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOBLATE ABLATION PEN

    MDR report key: 500310 · Received December 5, 2003

    Report

    Report Number
    2135394-2003-00006
    Event Type
    Death
    Date Received
    December 5, 2003
    Date of Event
    October 30, 2003
    Report Date
    November 7, 2003
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    ---
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED MITRAL VALVE AND TRICUSPID VALVE ANNULOPLASTY, TWO CORONARY GRAFTS AND AF ISOLATION WITH THE DEVICE (LEFT ATRIAL ABLATION). PATIENT RECEIVED TWO SUCCESSIVE RE-INTUBATIONS POST-OPERATIVELY. A CEREBRAL SCANNER DID NOT SHOW RECENT ISCHEMIA OR HEMORRHAGENIC STROKE. PATIENT ALSO RECEIVED FIBROSCOPY IN THE ICU DUE TO DIGESTIVE HEMORRHAGING. NO SPECIFIC LESION OBSERVED. PT EXPIRED. AUTOPSY REVEALED A LEFT ATRIO-ESOPHAGEAL FISTULA THAT IT IS REASONABLE TO ATTRIBUTE TO PARIETAL NECROSIS INDUCED BY RADIO FREQUENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOBLATE ABLATION PEN ABLATION PEN --- MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 60811C 2003060573

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death