BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1073135 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02377
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PORTION OF THE LEAD WAS RETURNED. ANALYSIS DID NOT REVEAL ANY LEAD CONDITION THAT WOULD HAVE CONTRIBUTED TO THE FIELD EXPERIENCE OF PERICARDIAL EFFUSION. THE LEAD TIP STIFFNESS","IS WITHIN SPECIFICATION. DRIED BODY FLUID/TISSUE INSIDE THE HEADER AND INNER INSULATION PREVENTED HELIX EXTENSION. AFTER CLEANING AND CUTTING, NORMAL HELIX MECHANISM WAS FOUND. THE RETURNED PORTION OF THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. WITHOUT RETURN OF THE ENTIRE LEAD, A","COMPLETE EVALUATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERICARDIAL EFFUSION WAS OBSERVED A FEW DAYS BEFORE A PLANNED UPGRADE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention