BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2780971 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13264
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. DURING THE EXPLANT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD'S COIL SEPARATED FROM THE TIP AT THE RING ELECTRODE, AND THIS PORTION REMAINS IN THE PATIENT'S HEAT. THE PHYSICIAN HAS NO PLANS TO REMOVE THE LEAD AT THIS TIME. FURTHERMORE, THE PHYSICIAN BELIEVES THE LASER MAY HAVE DAMAGED THE LEAD'S INSULATION AT THIS POINT, THUS CAUSING THE LEAD TO BE ABANDONED SURGICALLY. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 1290| K063| 4473| 4472