BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1073507 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02401
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 21, 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
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED AS RECEIVED, THE LEAD WAS RETURNED IN TWO PIECES AND WAS PHYSICALLY DAMAGED. ANALYSIS NOTED ABRASIONS AT 13CM AND 17.5CM FROM CONNECTOR PIN, CONSISTENT WITH THAT CAUSED BY FRICTION WITH THE ICD CAN. THE ETFE INSULATION OF THE PROXIMAL CABLE WAS ALSO DAMAGE AT APPROXIMATELY 17.5 CM FROM CONNECTOR, WHICH COULD HAVE CAUSED THE REPORTED NOISE.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO NOISE.

    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 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention