BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2173771 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10662
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) DEVELOPED A RASH OVER THE TOP OF THE CAN. AT THIS TIME, IT IS UNCERTAIN IF THIS IS AN INFECTION OR AN ALLERGIC REACTION. IT WAS NOTED THAT BLOOD WAS DRAWN FOR TESTING PURPOSES. ADDITIONAL INFORMATION INDICATED THE ISSUE HAS NOT BEEN CONFIRMED. AT THIS TIME, BLOOD TESTS WILL BE PERFORMED AND A LIST OF MANUFACTURING MATERIALS IN THE CAN WILL BE PROVIDED TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4469| S606| 4136