BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1861031 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15272
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A POCKET REVISION WAS PERFORMED DUE TO POCKET EROSION. THERE WAS NO SIGN OF INFECTION AND THE CULTURE WAS NEGATIVE. THE EXPOSED SUTURE SLEEVE WAS CUT OFF AND THE SYSTEM WAS RE-IMPLANTED AND RE-SUTURED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE POCKET REVISION 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 86 YR Required Intervention 4456| 4469| S603