BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2042282 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02323
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    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

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. THE CONSULTANT EXPRESSED CONCERN REGARDING THE PERFORMANCE OF THIS LEAD. ACCORDING TO OUR RECORDS, THE LEAD REMAINS ACTIVELY IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS, NOISE, SMALL P-WAVES AND SOME UNDERSENSING. THE CALLER ALSO REPORTED THAT LOSS OF CAPTURE WAS OBSERVED WITH THE ASSOCIATED RIGHT VENTRICULAR LEAD DURING ATRIAL SENSING TESTS IN DDD CONFIGURATION. A REVIEW OF THE ASSOCIATED STRIPS SHOW POTENTIAL OVERSENSING WITH SOME PACING INHIBITION. THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR S208| 1284| 4472| 4458