BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073039 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02289
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 22, 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 Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED NOISE WAS NOT CONFIRMED IN THE LABORATORY. ANALYSIS FOUND THE LEAD TO EXHIBIT NORMAL ELECTRICAL CHARACTERISTICS. NORMAL LEAD IMPEDANCE WAS MEASURED. FURTHER 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 52 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 NOISE AND POOR SENSING WERE OBSERVED ON THE RV LEAD. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention