BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB

    MDR report key: 1994243 · Received January 14, 2011

    Report

    Report Number
    2030404-2011-00012
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONNECTION TUBE BETWEEN THE HANDLE AND IRRIGATION LINE BROKE AT THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB NONE OAD ST JUDE MEDICAL, IRVINE 83563 3194233

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK