BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2910666 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15623
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16328 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 4470| 1230| 4542| H177| H217| 4538| 1284| 0158| N141| 4058M