BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2781001 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13093
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    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

    THE LEAD WAS SURGICALLY CAPPED AND ABANDONED AND A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. 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 DURING A ROUTINE DEVICE REPLACEMENT, THIS RIGHT ATRIAL (RA) LEAD WAS OBSERVED TO HAVE FRACTURED AT THE PROXIMAL SECTION OF THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4479| T165| N141| 0184| 4543| MISMATCH