BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2890039 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10752
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE LEAD TIP MEASURING 50.8CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASIONS WERE NOTED AT 7.7-8.2CM AND 8.1-8.8CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP. X-RAY REVEALED EXTERNALIZED CONDUCTORS. NO ELECTRICAL ANOMALIES WERE FOUND. LEAD WILL BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THAT THE LEAD WAS EXTRACTED AND REPLACED DURING AN ELECTIVE GENERATOR CHANGE-OUT. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR