BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1862138 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16262
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE COMPLETE LEAD WAS RETURNED. AT 27.5 CM FROM THE TERMINAL PIN, THE LEAD INSULATION WAS RUPTURED AND ALL CONDUCTOR COILS UNDERNEATH WERE FRACTURED. THE CONDUCTOR COILS WERE NOT ELECTRICALLY CONTINUOUS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD'S DISPLAYED LOSS OF CAPTURE, NO SENSING AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. LEAD FRACTURE'S WERE DISCOVERED DUE TO CLAVICULAR CRUSH. THE RA AND RV LEAD'S WERE EXPLANTED AND NEW RA AND RV LEAD'S WERE SUCCESSFULLY IMPLANTED. OTHER THAN THE PROCEDURE, 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 66 YR Life Threatening| R S606| 4457| 4469