BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1831983 · Received September 7, 2010

    Report

    Report Number
    2030404-2010-00125
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ST. JUDE MEDICAL
    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

    EVALUATION OF THE RETURNED CATHETER REVEALED THAT THE COMPLAINT COULD NOT BE DUPLICATED. FUNCTIONAL TESTING REVEALED THE CATHETER MET ALL SPECIFICATIONS. NO ANOMALIES WERE FOUND WITH THIS CATHETER. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE CATHETER HANDLE LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUP 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB NONE OAD ST. JUDE MEDICAL 83565 K26940

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK