BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4131772 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14393
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER, RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE NOISE WAS OVERSENSED RESULTING IN PACING INHIBITION FOR UP TO THREE SECONDS. THE PATIENT WAS PACEMAKER DEPENDENT AND EXPERIENCED NEAR SYNCOPE. ADDITIONALLY, THE RV LEAD EXHIBITED SPIKES IN PACING IMPEDANCE MEASUREMENTS UP TO 2,000 OHMS. NOISE WAS ABLE TO BE REPRODUCED WITH PATIENT ISOMETRICS, HOWEVER, NOT WITH POCKET MANIPULATIONS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL CAUSES AND ADDITIONAL TROUBLESHOOTING OPTIONS. THE DEVICE WAS PROGRAMMED DOO AND FURTHER TROUBLESHOOTING WAS PLANNED FOR A DATE IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612222 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R K063| 4472| 4473| 1298