BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 4140579 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17118
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRT-P AND RA LEAD REMAIN 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 NORMAL PATIENT FOLLOW UP, THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PRESENTED WITH PACING IMPEDANCE MEASUREMENTS ABOVE 2,500 OHMS, NO SENSING OR CAPTURE ON THE RIGHT ATRIAL (RA) LEAD. A REVIEW OF THE ARRHYTHMIA LOGBOOK SHOWED NUMEROUS EPISODES OF NOISE THAT WAS BEING OVERSENSED AS ATRIAL FIBRILLATION (AF). THE CRT-P WAS PROGRAMMED TO VVIR 70 AND THE PATIENT WILL BE SEEN AGAIN IN ANOTHER THREE MONTHS WHERE FURTHER EVALUATION AND A CHEST X-RAY WILL BE CONSIDERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618282 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4474

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4549| 4471| 4512| 1241| 4474| H140