BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1895890 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04341
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    July 18, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SENSING ANOMALY WAS CONFIRMED. ANALYSIS FOUND INSIDE OUT ABRASIONS AT 7.1CM TO 8.2CM, 11CM TO 14CM, AND 15.5CM TO 19.4CM FROM THE HELIX END. THE EFTE COATING ON ONE OF THE RV CABLES WAS ALSO ABRADED BETWEEN 11CM AND 14CM FROM THE HELIX END. ABRASIONS DUE TO FRICTION WITH THE ICD CAN, WERE NOTED BETWEEN 52.2CM AND 52.6CM AND BETWEEN 60CM AND 60.8CM FROM THE HELIX END. DUE TO THE LEAD CONDITION, FURTHER ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE DUE TO DELAY IN RECEIVING PAPERWORK. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO A SENSING ANOMALY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention