BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1073530 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02424
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 7, 2007
    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 Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED HIGH THRESHOLDS WERE NOT CONFIRMED IN THE LABORATORY. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. MECHANICAL AND VISUAL ANALYSIS FOUND THE LEAD HELIX COULD NOT BE EXTENDED DUE TO DRIED BODY FLUID IN THE LEAD DISTAL COIL AND HELIX. THE LEAD WAS CUT AT 49 CM FROM THE CONNECTOR PIN. THE HELIX COULD BE FULLY EXTENDED AND RETRACTED BY APPLYING TORQUE DIRECTLY TO THE DISTAL COIL OF THE REMAINING PORTION OF THE LEAD. NO DEFECTS IN MATERIALS OR WORKMANSHIP WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST DISCOMFORT POST IMPLANT. HIGH CAPTURE THRESHOLD WAS OBSERVED. THE LEAD WAS REMOVED WHEN AN ATTEMPT TO REPOSITION WAS UNSUCCESSFUL.

    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 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention