BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1073123 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02365
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 10, 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 THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTIS. MECHANICAL AND VISUAL ANALYSIS FOUND THE LEAD HELIX COULD NOT BE EXTENDED DUE TO DRIED BODY FLUID IN THE DISTAL COIL AND HELIX. FURTHER ANALYSIS FOUND THE DISTAL COIL WAS TWISTED AND STRETCHED NEAR THE CONNECTOR PIN DUE TO OVER-TORQUE OF THE DISTAL COIL. NONE OF THE COIL WIRES WERE BROKEN. THERE IS NO INDICATION OF DEFECTS IN MATERIALS OR WORKMANSHIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW R-WAVES WERE OBSERVED ON THE LEAD. A REPOSITION WAS UNSUCCESSFUL AND THE LEAD WAS REPLACED.

    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