BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1771346 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12399
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    October 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IMPLANTED. AS A RESULT, BOSTON SCIENTIFIC CRM IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED SEVERED LEAD WITH ONLY 72MM OF THE PROXIMAL SEGMENT RETURNED. DRIED BODY FLUID WAS ALSO NOTED THROUGHOUT THE LEAD LUMEN. FIELD ALLEGATION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE LEAD SAFETY SWITCH TRIPPED ON THE RIGHT VENTRICULAR LEAD DUE TO UNKNOWN IMPEDANCE MEASUREMENTS. THE LEAD WILL BE MONITORED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT EXPIRED DUE TO NON-DEVICE RELATED REASONS. THE LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening 1291| 4469| 4470