BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1947100 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-22269
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 22, 2010
    Report Date
    November 30, 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

    AT THIS TIME, THIS LEAD IS UNDERGOING ANALYSIS. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THAT THE LEAD AND CONDUCTOR COILS WERE TWISTED AT 120 - 270 MILLIMETERS FROM THE TERMINAL PIN. RESISTANCE AND PRESSURE TEST WERE USED TO TEST ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS WITH NO CAPTURE. IT WAS NOTED THAT THIS COULD BE A CASE OF POSSIBLE TWIDDLER'S SYNDROME. THE PHYSICIAN REPROGRAMMED THE DEVICE AND THE PATIENT WAS IN A SINUS RHYTHM. IT WAS ALSO NOTED THAT THE LEADS WOULD BE EVALUATED IN THE NEXT FEW WEEKS. ADDITIONAL INFORMATION CONFIRMED TWIDDLER'S SYNDROME. A REVISION PROCEDURE WAS PERFORMED AND THE RA LEAD WAS FOUND TO BE FRACTURED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. 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 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention 4470| N119| 0185| 4592