BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2153586 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06274
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM REMAINS IMPLANTED 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 RECEIVED INFORMATION THAT THIS PATIENT BELIEVES HIS PACEMAKER POCKET IS INFECTED. THERE IS SWELLING AND A BUMP AT THE DEVICE AREA. THE PATIENT WAS INQUIRING IF AN INFECTION IS COMMON AFTER FIVE MONTHS OF IMPLANT TIME AND ALSO IF PEOPLE HAVE ALLERGIC REACTIONS TO TITANIUM. THE PATIENT HAD TESTING PERFORMED AT HIS PHYSICIAN'S OFFICE; IT IS UNKNOWN IF THE TESTING WAS FOR THE SUSPECTED INFECTION OR ALLERGY TESTING. THE RESULTS OF THE TESTING WERE NOT PROVIDED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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 75 YR 4457| 4470| S603