BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2911839 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16556
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE WITH NO INTERVENTION PERFORMED. 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 VENTRICULAR (RV) LEAD HAD MOVED FROM THE APEX TO THE CORONARY SINUS. PACING THRESHOLD MEASUREMENTS HAD INCREASED SINCE THE IMPLANT PROCEDURE. THE DISLODGMENT WAS OBSERVED VIA CT SCAN; PERFORATION AND CARDIAC TAMPONADE WERE NOT OBSERVED. SENSING AND IMPEDANCE MEASUREMENTS WERE NORMAL, AND PACING WAS DELIVERED PROPERLY. THE PATIENT AND LEAD WILL BE EVALUATED AT THE NEXT DEVICE FOLLOW-UP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18990 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1