BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1874708 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17676
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 7, 2010
    Report Date
    September 6, 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

    A NEW PACING SYSTEM WAS SUCCESSFULLY IMPLANTED. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO BOSTON SCIENTIFIC CRM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER AND LEAD WERE EXPLANTED, DUE TO INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention