BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1771409 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12544
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 8, 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

    NO OTHER ADVERSE PATIENT EFFECTS HAVE BEEN OBSERVED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED DUE TO A PATIENT INFECTION. IT WAS REPORTED THAT THE CULTURE OF THE PATIENT'S POCKET WAS POSITIVE FOR (B)(6).

    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 71 YR Required Intervention 0158| 4470| E110