BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB

    MDR report key: 1935846 · Received December 3, 2010

    Report

    Report Number
    2030404-2010-00254
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 12/03/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HANDLE LEAK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83565 K26742

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK