BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY COOL PATH

    MDR report key: 1718009 · Received May 27, 2010

    Report

    Report Number
    1718009
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    March 25, 2010
    Report Date
    May 26, 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 WOULD NOT DEFLECT PROPERLY. THIS WAS AN OUT-OF-BOX FAILURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================EP- EQUIP/SUPPLIES/PRODUCT OUT-OF-PACKAGE FAILURE====================== 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 * K24481

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR