BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2050231 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03375
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION REVEALED THE CONDUCTOR COILS WERE EXTREMELY STRETCHED AND EXTEND BEYOND THE END OF THE INSULATION. THE ANODE AND CATHODE CONDUCTOR COIL ENDS APPEARED TO HAVE BEEN PULLED TO THE POINT OF FRACTURE. THE INSULATION TOWARD THE DISTAL END WAS WHITE FROM BEING STRETCHED. THERE WAS A PIECE OF INSULATION AND TISSUE ENTANGLED ON THE STRETCHED CONDUCTOR COILS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THIS SYSTEM UPGRADE PROCEDURE, THE DECISION WAS MADE TO REPLACE THE RIGHT ATRIAL LEAD. THE LEAD HAD UN-TETHERED AND BROKEN IN THE POCKET. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention N119| 4542| 0184| S603| 4470| 4469