BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1851473 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14120
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING POST IMPLANT TESTING, THIS RIGHT VENTRICULAR LEAD DISPLAYED INTERMITTENT LOSS OF CAPTURE, INCREASED THRESHOLD MEASUREMENTS AND UNDERSENSING. THRESHOLD MEASUREMENTS VARIED ACCORDING TO THE PATIENT'S CONDITION. THE DEVICE WAS REPROGRAMMED. THE PATIENT WITH THIS LEAD HAS AN UNDERLYING CARDIAC INTRINSIC RHYTHM OF ATRIAL FIBRILLATION, IS NOT PACEMAKER DEPENDENT AND REMAINED HOSPITALIZED. A CHEST X-RAY WAS PERFORMED REVEALING THE LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS SUCCESSFULLY REPOSITIONED. POST OPERATIVE MEASUREMENTS WERE WITHIN NORMAL LIMITS AND THE DEVICE WAS SENSING AND PACING APPROPRIATELY. 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 4457

    Patients

    Seq Age Sex Outcome Treatment
    1