BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEV

    MDR report key: 630435 · Received August 25, 2005

    Report

    Report Number
    3002648230-2005-00005
    Event Type
    Other
    Date Received
    August 25, 2005
    Date of Event
    August 8, 2005
    Report Date
    August 24, 2005
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING TREATED FOR AVNRT. A BRIEF FREEZE MAP WAS PERFORMED WITH PROGRESSVIE ADVANCE UP THE STERNUM, DURING THE 22ND MAP, THE ARRHYTHMIA BROKE AND WAS FOLLOWED BY 15 MINUTES OF COMPLETE HEART BLOCK. THE CHE WAS RESOLVED LEAVING A PROLONGED PR INTERVAL OF 215MS. THE PROCEDURE WAS STOPPED AND A TEMPORARY PEACEMAKER WAS INSERTED OVERNIGHT. AFTER 24H, THE PATIENT CONDUCTION WAS BACK TO NORMAL SINUS RHYTHM AND NO PERMANENT PEACEMAKER WAS REQUIRED. THE DEVICE DID NOT MALFUNCTION. THIS EVENT CONSTITUTES A SERIOUS INJURY BECAUSE THE ABLATION WAS HALTED AND FURTHER MEDICAL INTERVENTION WAS REQUIRED; TEMPORARY PEACEMAKER WAS IMPLANTED OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEV CARDIOVASCULAR DEVICE (CRYOCATHETER) GEH CRYOCATH TECHNOLOGIES, INC. 227F5 50218

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention