BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1945056 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20171
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. 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 CRM RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS EXHIBITING INTERMITTENT IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. ADDITIONALLY, NOISE WAS REPRODUCIBLE WITH ISOMETRICS WHICH RESULTED IN INAPPROPRIATE MODE SWITCHES DUE TO OVERSENSING. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER. ADDITIONALLY, THE CONSULTANT PROVIDED DETAILS ON REPROGRAMMING OPTIONS. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS FOUND TO BE FRACTURED. THEREFORE, THE LEAD WAS REMOVED FROM SERVICE. 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 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0148| 4480| T180