BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1954132 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24293
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTED LEAD WAS ASSOCIATED WITH A DEVICE EXPLANT DUE TO INFECTION. THE LEAD REMAINS IMPLANTED AND IN SERVICE WITH A COMPETITORS DEVICE REPLACEMENT. THE PHYSICIAN STATED THE INFECTION WAS NOT PROCEDURE RELATED AS IT WAS NINE MONTHS POST IMPLANT; HOWEVER, WONDERED IF ANY ALLERGIC REACTIONS TO THE DEVICE COMPONENT STRUCTURE WERE A FACTOR. ADDITIONALLY, IT WAS REPORTED THE PATIENT HAD LEUKEMIA WITH A CORRESPONDING LOW WHITE BLOOD CELL COUNT, WHICH COULD HAVE LIKELY CONTRIBUTED TO SYSTEMIC INFECTION. NO ADDITIONAL 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 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention