BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2041801 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01017
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. DRIED BODY FLUID WAS NOTED IN THE HELIX LUMEN. THIS LIKELY WAS INTRODUCED THROUGH THE TERMINAL PIN. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED NO SENSING AND NO THRESHOLD MEASUREMENTS. IT WAS SUSPECTED THAT THE LEAD HAD DISLODGED. AS A RESULT, A REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS HAVE BEEN NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention S603| 4479| 4456