BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1874846 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18233
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE THE COMPANY WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISLODGED. DURING THE LEAD REVISION PROCEDURE, THE PATIENT MOVED RESULTING IN THE LEAD BEING DAMAGED. AS A RESULT, THIS LEAD WAS SURGICALLY ABANDONED.

    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 76 YR Required Intervention S403| 4470| 4471| 4469