BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1971478 · Received January 21, 2011

    Report

    Report Number
    2030404-2011-00018
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    October 11, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION IS UNKNOWN. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 01/21/2011. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN ABLATION PROCEDURE USING A THERAPY COOL FLEX CATHETER. FOLLOWING THE PROCEDURE, DURING THE PATIENT'S HOSPITALIZATION AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. THE PHYSICIAN BELIEVED THE EFFUSION WAS THE RESULT OF THE ABLATION PROCEDURE BUT DID NOT ATTRIBUTE IT TO THE USE OF THE COOL FLEX CATHETER. THERE WERE NO 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 K28196

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other THERAPY COOL FLEX CATHETER MODEL 88015, LOT K30884