BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1791287 · Received August 6, 2010

    Report

    Report Number
    2030404-2010-00078
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    IRVINE BIOMEDICAL, A ST JUDE MEDICAL COMPANY
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE DEVICE IS RECEIVED, WE WILL CONDUCT AN INVESTIGATION AND PROVIDE OUR FINDINGS IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ONE HOUR OF CATHETER MANIPULATION DURING AN AF CASE, WE NOTICED A LEAKAGE IN THE HANDLE.

    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 COMPANY 83563 K23154

    Patients

    Seq Age Sex Outcome Treatment
    1