BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2051705 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03936
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    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

    THE LEAD REMAINS 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 THIS RIGHT ATRIAL LEAD DISPLAYED IMPEDANCE MEASUREMENT GREATER THAN 2500 OHMS, NOISE AND LOSS OF CAPTURE. THE LEAD REMAINS IMPLANTED AND THE PACEMAKER WAS PROGRAMMED TO VVI MODE. THE LEAD MAY BE REPLACED IF THE PATIENT DOES NOT TOLERATE THIS MODE. 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 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR 1280| S606| 4285| 4472