BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1771563 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13139
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD THE PRODUCT GET RETURNED, ANALYSIS WOULD NOT BE REQUIRED DUE TO THE NATURE OF THE ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACING SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. THERE WERE NO ADVERSE PATIENT EFFECTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 4457| S606| 4087