BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1073605 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02489
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 7, 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
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE CAPTURE ANOMALY. VISUAL INSPECTION REVEALED AN INSULATION CUT AT 15.65 CM FROM THE CONNECTOR END, CONSISTENT WITH THAT OCCURRING AT THE TIME OF SURGICAL PROCEDURE. FUNCTIONAL TESTING REVEALED NORMAL LEAD CHARACTERISTICS. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO INTERMITTENT CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention