BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3050165 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04687
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    August 24, 2012
    Report Date
    February 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAS HAD EPISODES OF NOISE ON STORED LOGBOOK EVENTS SINCE (B)(6) SUMMER. SINCE (B)(6), THE PACING IMPEDANCES WERE CONSISTENTLY GREATER THAN 3000 OHMS ON DAILY MEASUREMENTS. NO ATRIAL CAPTURE WAS NOTED. DUE TO THE OBSERVATIONS WITH THE LEAD IT WAS PROGRAMMED OFF AND THE DEVICE WAS PROGRAMMED TO VVIR MODE. AN ECHO WAS GOING TO BE COMPLETED TO EVALUATE THE PATIENT'S EJECTION FRACTION AS AN LEFT VENTRICULAR (LV) LEAD IS BEING CONSIDERED AND THEN THE RA LEAD MAY BE REVISED AT THAT TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE LEAD REMAINS IN SERVICE AND NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149587 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0185| T165| 4470| 4471| 1298