BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1950975 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23264
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 20, 2007
    Report Date
    December 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED PROXIMAL SEGMENT WAS PERFORMED. VISUAL INSPECTION NOTED SEVERAL LOCATIONS WHERE THE TUBING WAS MELTED. RESISTANCE AND PRESSURE TESTING CONFIRMED THE ANODE CONDUCTIVE PATH WAS NOT ELECTRICALLY CONTINUOUS DUE TO MELTING WHICH EXPOSED THE ANODE CONDUCTOR. THE DAMAGE IS CONSISTENT WITH ELECTROCAUTERY DAMAGE MOST LIKELY OCCURRING DURING THE EXPLANT PROCEDURE. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUBSEQUENTLY RETURNED AND IS BEING EVALUATED IN BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS VENTRICULAR LEAD HAD BEEN EXHIBITING RISING IMPEDANCE MEASUREMENTS RANGING FROM 350 OHMS TO 720 OHMS NOTED IN (B)(6)2007. ALL OTHER LEAD MEASUREMENTS WERE ACCEPTABLE AND THERE WERE NO STORED EPISODES. THE PATIENT'S PHYSICIAN WAS GOING TO PERFORM A CHEST X-RAY AND CONTINUE TO MONITOR THE LEAD. THREE YEARS LATER, THE LEAD SAFETY SWITCH (LSS) HAD BEEN TRIGGERED DUE TO OUT OF RANGE VENTRICULAR IMPEDANCE MEASUREMENTS. THEREFORE, A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 4470| 1170