BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH 7F, 1304-CP-7-25-M

    MDR report key: 1881976 · Received October 12, 2010

    Report

    Report Number
    2030404-2010-00185
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR EVALUATION HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER HAD A HANDLE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-M NONE OAD ST. JUDE MEDICAL, IRVINE 83352 K12541

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK