BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 1699505 · Received May 26, 2010

    Report

    Report Number
    2124215-2010-11648
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE MONTH POST IMPLANT OF THIS PACING SYSTEM, THIS PATIENT PASSED AWAY DUE TO NON-CARDIAC RELATED ISSUES. IT WAS NOTED THAT THE PATIENT HAD AN INFECTION, BUT NOT AT THE SITE OF THE PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death S601| 4471