BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1073106 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02348
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    February 21, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EXPERIENCE WAS CONFIRMED. ANALYSIS FOUND ABRASION/DAMAGED TO THE OUTER AND ETFE INSULATION AT 13.2 CM FROM THE CONNECTOR PIN, CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN. THE CONDITION OF THE INSULATIONS COULD COULD HAVE CAUSED SENSING ANOMALY. FURTHER ANALYSIS ALSO NOTED STYLET OBSTRUCTION AT THE CONNECTOR PIN AREA DUE TO AN OVER-TORQUE TO THE DISTAL COIL.

    Description of Event or Problem · 1

    T-WAVE OVERSENSING AND LOW R-WAVES WERE OBSERVED. AS A RESULT, INAPPROPRIATE THERAPY WAS DELIVERED. THE LEAD WAS EXPLANTED.

    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