BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1863727 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16203
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS ADDRESSED SECONDARY TO POCKET EROSION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS IMPACTED BY POCKET EROSION. A NEW DEVICE WAS IMPLANTED ONCE THE PATIENT WAS CLEARED BY THE PHYSICIAN. THE THREE LEADS IN THE SYSTEM REPORTED SEPARATELY, HAD REMAINED IN SERVICE.

    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 72 YR 1298| 4470| H219| 4518| 0184| N118| 4469