BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2984371 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00307
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASIONS WERE NOTED AT 7.1-8.3CM FROM THE TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART AND AT 42.3-42.5CM FROM THE TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 29.7-32.5CM FROM THE TIP ELECTRODE. INTERNAL INSULATION ABRASIONS WERE NOTED AT 13.5-13.9CM, 14.7-15.5CM, 17.2-17.4CM, 18.5-18.9CM, AND 33.4-33.8CM FROM THE TIP ELECTRODE. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 28.5-28.7CM FROM THE TIP ELECTRODE. THE ETFE COATING WAS INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A NORMAL FOLLOW UP. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87692 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR