BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1851286 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14488
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND ALL TESTING WAS WITHIN NORMAL LIMITS. 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 ONE WEEK POST IMPLANT, SYSTEM EVALUATION NOTED COMPLETE LOSS OF VENTRICULAR CAPTURE. THEREFORE, A REVISION PROCEDURE WAS PERFORMED. IT WAS REVEALED THAT THIS RIGHT VENTRICULAR LEAD HAD DISLODGED. THE PATIENT HAS TWIDDLERS SYNDROME AND THIS LEAD AND THE ASSOCIATED ATRIAL LEAD WERE WRAPPED AROUND EACH OTHER APPROXIMATELY TEN TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR S603| 4470| 4471