BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1874003 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17887
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE LEAD IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE PATIENT ALSO HAD EXPERIENCED DEVICE POCKET EROSION, POSSIBLY DUE TO THE INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R 0184| 4469| 4542| N119