BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1874980 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17990
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE ON THE TRANS TELEPHONIC MONITORING (TTM) SYSTEM. A MAGNET STRIP WAS OBTAINED WHERE IT SHOWED ASYNCHRONOUS AV PACING AT 100BPM WITH POSSIBLE VENTRICULAR LOSS OF CAPTURE WITH FUSED BEATS, AND THE STRIP WAS UNABLE TO EVALUATE ANY ATRIAL CAPTURE. TECHNICAL SERVICES ADVISED CONTACTING THE PHYSICIAN TO DISCUSS. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening S602| 4469| 4456