BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2063127 · Received March 22, 2011

    Report

    Report Number
    2030404-2011-00081
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ABLATION PROCEDURE, A "STEAM POP" OCCURRED DURING RF DELIVERY IN THE RIGHT ATRIUM AT 35W AND 30 DEGREES CELSIUS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1