BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1874094 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19812
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTING WAS PERFORMED WHICH CONFIRMED THE ELECTRICAL CONTINUITY OF THE LEAD. LABORATORY TESTING CANNOT CONFIRM THE OBSERVED CLINICAL OBSERVATION OF DISLODGEMENT. HOWEVER, EVIDENCE AND PAST EXPERIENCE SUGGESTS THAT LEAD DISLODGEMENT CAN BE THE RESULT OF UNIQUE PATIENT PHYSIOLOGY AND /OR IMPLANT TECHNIQUE (WHICH IS OFTEN DICTATED BY PATIENT ANATOMY). LEAD DISLODGEMENT IS A POTENTIAL COMPLICATION OF IMPLANTABLE PACING AND IS DESCRIBED IN DEVICE LABELING. BOSTON SCIENTIFIC CRM WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THAT NO LEAD DISPLAYS AN ABNORMAL RATE OF OCCURRENCE. 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 PATIENT HAD EXPERIENCED A SYNCOPAL EPISODE. IT WAS OBSERVED THAT THIS RIGHT VENTRICULAR LEAD WAS EXHIBITING INCREASED THRESHOLD MEASURMENTS AND DECREASED IMPEDANCE MEASUREMENTS DUE TO DISLODGEMENT. 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 67 YR 4470| 4469| S404| 4087