BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3252020 · Received July 29, 2013

    Report

    Report Number
    2124215-2013-12080
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 13, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION REVEALED THAT THE CONDUCTOR COILS WERE SEPARATED FROM THE TERMINAL PIN AND THE INSULATION WAS PUNCTURED DUE TO THE STYLET. CUTS ON THE INSULATION WERE ALSO NOTED. THE LEAD UNDERWENT THE STYLET INSERTION AND CONTINUITY TESTS WITH MANIPULATION AND PASSED. NO FURTHER ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS BRADY LEAD HAD A CONDUCTOR FRACTURE AND INSULATION DAMAGE, WHICH WAS OBSERVED DURING IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS NEVER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353808 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1