BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1873793 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17349
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, IT WAS NOTED THIS RIGHT VENTRICULAR LEAD DISPLAYED POOR SENSING AND INCREASED THRESHOLD MEASUREMENTS. IN ADDITION, AS THE LEAD HAD NOT BEEN IMPLANTED INTO THE TISSUE WELL; THE LEAD APPEARED STRETCHED. IT WAS THOUGHT THIS LEAD MAY HAVE MICRODISLODGED. IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. A REVISION PROCEDURE WAS PERFORMED, THE LEAD WAS SUCCESSFULLY REPOSITIONED, HOWEVER DIFFICULTY WAS ENCOUNTERED DURING THE PROCEDURE AS THE LEAD WAS ADHERED TO THE TRABECULA. MEASUREMENTS POST OPERATIVELY WERE WITHIN NORMAL LIMITS. 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 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention