BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1945706 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20179
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OBSERVATION. THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT DISCUSSED THE POSSIBILITY OF A LEAD PROBLEM. AVAILABLE INFORMATION SUGGESTS THAT THE PHYSICIAN MAY MONITOR THE SITUATION AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS EXHIBITING INTERMITTENT FLUCTUATIONS IN PACING IMPEDANCE MEASUREMENTS, WITH SOME MEASUREMENTS GREATER THAN 2000 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4474

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 0158| 4474| 4525| H173| N118