BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1791681 · Received August 4, 2010

    Report

    Report Number
    2030404-2010-00090
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 2010
    Manufacturer
    IRVINE BIOMEDICAL, A ST. JUDE MEDICAL CO
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN TRANSIT TO THE MFR AND NOT RECEIVED AS OF 07/05/2010. ONCE THE DEVICE IS RECEIVED, WE WILL CONDUCT AN INVESTIGATION AND PROVIDE OUR FINDINGS IN A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IRRIGATION FLUID WAS DRIPPING FROM THE HANDLE OF THE CATHETER. THE GENERATOR THEN STOPPED ABLATION BECAUSE THE SET TEMPERATURE LIMIT WAS EXCEEDED. THIS HAPPENED AFTER HAVING USED THE CATHETER SUCCESSFULLY FOR ABOUT ONE AND A HALF HOURS FOR AN AF ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY ABLATION CATHETER CARDIAC PERCUTANEOUS ABLATION CATHETER OAD IRVINE BIOMEDICAL, A ST. JUDE MEDICAL CO 83562 K25858

    Patients

    Seq Age Sex Outcome Treatment
    1