BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223426 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03655
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    November 16, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS BASED ON ANALYSIS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED RELIABILITY LABORATORY TECHNICIAN. ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. THE LEAD WAS RETURNED IN TWO PIECES. INSULATION ABRASIONS WERE OBSERVED ON BOTH PORTIONS OF THE LEAD. THE ETFE INSULATION ON THE PROXIMAL CABLES WAS ABRADED DUE TO FRICTION TO THE ICD CAN. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS ON EACH PORTION.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD APPEARED TO BE FRACTURED. EGMS SHOWED NOISE AND SHOCKS. THE R-WAVE AMPLITUDE HAD DECREASED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention