BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY COOL PATH

    MDR report key: 1710430 · Received May 10, 2010

    Report

    Report Number
    1710430
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    March 16, 2010
    Report Date
    May 10, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER TIP WAS BENT BEFORE IT WAS USED. IT WAS AN OUT-OF-PACKAGE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH CATHETER, ABLATION, CARDIAC, EP OAD ST. JUDE MEDICAL * K21374

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR