BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY COOL PATH

    MDR report key: 1749119 · Received May 22, 2010

    Report

    Report Number
    1749119
    Event Type
    Malfunction
    Date Received
    May 22, 2010
    Date of Event
    March 23, 2010
    Report Date
    May 22, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    CATHETER DID NOT DEFLECT PROPERLY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================N/A====================== MANUFACTURER RESPONSE FOR THERAPY COOL PATH, THERAPY COOL PATH======================AWAITING RESPONSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH CATHETER, ABLATION, CARDIAC, RF OAD ST. JUDE MEDICAL * K24638

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR