BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1952622 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23586
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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 DURING A DEVICE EXPLANT FOR NORMAL BATTERY DEPLETION, NOISE WITH GREATER THAN TWO SECONDS OF PACING INHIBITION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE CAUSE OF THE NOISE WAS UNKNOWN. THE PHYSICIAN ALSO STATED THAT THE ATRIAL CHANNEL EXHIBITED PAUSES IN PACING. BOSTON SCIENTIFIC TECHNICAL SERVICES CONFIRMED THE TIMING PATTERN AND WHY THERE WAS NO ATRIAL PACING. THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. 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 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 4470| 1298| 4471