BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2053020 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04418
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 4, 2011
    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 INSPECTION CONFIRMED THAT THE LEAD WAS RETURNED SEVERED AT 215 MM FROM THE TERMINAL PIN, THERE WERE 2 SEGMENTS RETURNED, AND THE TOTAL LENGTH WAS 525 MM. THERE WAS DRIED BODY FLUID FOUND THROUGH OUT THE ENTIRE LEAD LUMEN, AND AN EXTRACTION STYLET WAS STILL STUCK INSIDE THE LEAD. THERE WERE DEFORMED CONDUCTOR COILS AT 237 MM FROM THE TERMINAL PIN, POSSIBLY DUE TO SUTURE TIE DOWN. THERE WAS EVIDENCE OF ELECTRO-CAUTERY DAMAGE IN THE FORM OF MELTED INSULATION: 237 MM FROM THE TERMINAL PIN. THE CONDUCTOR COILS WERE STRETCHED 495 - 505 MM FROM THE TERMINAL PIN, MOST LIKELY DUE FROM EXPLANT. THERE WAS TISSUE ENTWINED IN THE HELIX. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE UPGRADE PROCEDURE, THIS LEAD WAS UNDER FLOUROSCOPY AND SHOWED SIGNS OF IMPENDING INSULATION DAMAGE. ALTHOUGH THE LEAD WAS FUNCTIONING AS DESIGNED, THE DECISION WAS MADE TO EXPLANT AND REPLACE TO AVOID A REPEATED SURGERY. 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 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR 4470| S603| 5076| 4457| 1290| 4469