BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB

    MDR report key: 2002401 · Received January 28, 2011

    Report

    Report Number
    2030404-2011-00023
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A F/U REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MFR: (B)(4) 2011. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ABLATION THE IRRIGATION LINE DISCONNECTED ITSELF FROM THE HANDLE OF THE CATHETER. A NEW DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB NONE OAD ST. JUDE MEDICAL, IRVINE 88016 3212739

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK