BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2172913 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-11025
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE LEAD NOTED SEVERAL CUTS WHICH WERE MOST LIKELY DUE TO THE REMOVAL OF THE SUTURE SLEEVE. RESISTANCE TESTING CONFIRMED THE LEAD WAS ELECTRICALLY CONTINUOUS. FINAL ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS OF DECREASED R-WAVE MEASUREMENTS AND LOSS OF CAPTURE DUE TO DISLODGEMENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY BEING ANALYZED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING DECREASED R-WAVE MEASUREMENTS AND LOSS OF CAPTURE ONE DAY POST IMPLANT DUE TO DISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention