BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2050235 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-02963
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE NOT RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER, RIGHT VENTRICULAR LEAD, AND ATRIAL LEAD WERE REMOVED AND REPLACED DUE TO AN INFECTION. AT THE PREVIOUS FOLLOW UP VISIT IN (B)(6), 2010, REDDENING OF THE POCKET SCAR WAS NOTED. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO BOSTON SCIENTIFIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Required Intervention