BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1852706 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14537
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT REMAINS IN SERVICE, IT WILL NOT BE RETURNED FOR ANALYSIS AND BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE, OR TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AN ERROR MESSAGE APPEARED UPON DEVICE INTERROGATION THAT REVEALED THE LEAD SAFETY SWITCH TRIGGERED FOR THIS RIGHT VENTRICULAR (RV) LEAD. REGARDING THE VENTRICULAR CHANNEL, THERE WAS A LOSS OF CAPTURE, ARTIFACT PACING, AND A RATE BELOW THE PROGRAMMED LOWER RATE LIMIT. REVIEW OF THE DAILY MEASUREMENTS INDICATED AN IMPEDANCE VALUE GREATER THAN 2500OHMS. AT THE LAST VISIT SIX MONTHS AGO, FOLLOWING A PREVIOUS LEAD REVISION TO IMPLANT THIS CURRENT LEAD, THE DMS WERE NORMAL. THE PATIENT REPORTED FEELING GREAT AND NO ADVERSE EFFECTS WERE REPORTED IN ASSOCIATION WITH THIS OBSERVATION. A LEAD REVISION PROCEDURE WILL BE SCHEDULED TO INVESTIGATE THE ISSUE FURTHER.

    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 69 YR Life Threatening 4456| S201