BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1831060 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03224
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 8, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    CAPTURE ANOMALY AND HIGH THRESHOLD WERE OBSERVED ON RV LEAD. UPON REMOVING THE LEAD FROM THE HEADER, THE PIN WAS FOUND BROKEN. THE PATIENT BECAME SEPTIC FROM UTI. THE LEAD WAS REMOVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER DID NOT PASS A PORTION OF THE RETURNED PRODUCTS TESTING, SUGGESTING A POSSIBLE PERFORMANCE ISSUE.

    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 1580/60

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention