BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2151604 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06645
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. NO DATE/INITIALS ARE NEEDED HERE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISPLAYED POOR P WAVE MEASUREMENTS, HIGH THRESHOLD MEASUREMENTS AND INTERMITTENT LOSS OF CAPTURE. DURING THE PRE-DISCHARGE CHECK, THE PATIENT WAS FOUND TO BE IN ATRIAL FLUTTER RHYTHM WITH LOSS OF CAPTURE. A TECHNICAL SERVICE CONSULTANT REVIEWED AN ELECTROGRAM AND SUSPECTED THAT THE LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED TWO DAYS POST IMPLANT. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)