BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEZOR XTRA

    MDR report key: 479794 · Received August 27, 2003

    Report

    Report Number
    3002648230-2003-00001
    Event Type
    Malfunction
    Date Received
    August 27, 2003
    Date of Event
    July 31, 2003
    Report Date
    August 26, 2003
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    Removal / Correction Number
    0000000-08/26/2003-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT BECAME ACUTELY UNRESPONSIVE AND APNEIC AT THE END OF A CRYOABLATION PROCEDURE FOR ATRIAL FLUTTER AT HOSPITAL. PT WAS TREATED WITH OXYGEN BY FACE MASK, RECOVERED IN A FEW MINUTES, AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR XTRA CARDIOVASCULAR DEVICE (CATHETER) NFC CRYOCATH TECHNOLOGIES, INC. 217F5 (EUROPE ONLY) 21201

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening