BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1953776 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24177
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 11, 2010
    Report Date
    January 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THE CONDUCTOR COILS WERE DEFORMED AT 128 MM FROM THE TERMINAL PIN. THE DAMAGE TO THE CONDUCTOR COILS WAS CONSISTENT WITH DAMAGE CAUSED DURING THE EXPLANT PROCEDURE. RESISTANCE AND PRESSURE TESTS WERE THEN COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL PACING LEAD DISLODGED ONE DAY POST IMPLANT. THE POCKET WAS REOPENED. THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention 5568| 4479| S606| 4136