BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1864039 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15913
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED. IT WAS FOUND TO BE DEFORMED (SLIGHTLY SEPARATED) CONDUCTOR COILS ALONG WITH A SMUDGE ON THE INNER INSULATION NOTED 570MM FORM THE TERMINAL PIN, IN THE NECK REGION. THIS WAS MOST LIKELY CAUSED BY THE STYLET ESCAPING THE LUMEN. THERE WAS NO MANNITOL COATING THE LEAD TIP AND THE HELIX WAS EXTREMELY STRETCHED AND BENT.THERE WAS TISSUE NOTED ENTWINED IN THE LEAD HELIX. ANALYSIS COULD NOT CONFIRM THAT THE HELIX GOT CAUGHT ON THE LEAD, HOWEVER THE HELIX IS STRETCHED AND BENT. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AT THE IMPLANT PROCEDURE THIS LEAD BUCKLED BACK ON ITSELF AND THE HELIX BECAME CAUGHT ON THE LEAD BODY. THE PHSYCIAN ELECTED TO EXPLANT THE LEAD, WHICH TOOK LONGER THAN EXPECTED, AND ANOTHER LEAD WAS USED IN IT'S PLACE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AT THE IMPLANT PROCEDURE THIS LEAD BUCKLED BACK ON ITSELF AND THE HELIX BECAME CAUGHT ON THE LEAD BODY. THE PHYSICIAN ELECTED TO EXPLANT THE LEAD, WHICH TOOK LONGER THAN EXPECTED, AND ANOTHER LEAD WAS USED IN IT'S PLACE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1