BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1073166 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02523
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 22, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. THE OUTER INSULATION WAS ABRADED AT 6.5 CM FROM THE CONNECTOR PIN DUE TO FRICTION WITH THE ICD CAN. THE OUTER INSULATION WAS ALSO ABRADED AT 20.4 CM FROM THE CONNECTOR PIN DUE TO DAMAGE OCCURRING DURING THE SURGICAL PROCEDURE. DRIED BODY FLUID WAS NOTED INSIDE THE HEADER, THE INNER INSULATION AND COIL, PREVENTING HELIX EXTENSION AND PROPER DISTAL COIL ROTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO OVERSENSING. AS A RESULT, THE PATIENT RECEIVED ONE INAPPROPRIATE SHOCK. AFTER THE LEAD WAS EXPLANTED, A LEAD ANOMALY WAS OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention