BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913286 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17178
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD AND PACEMAKER 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 FOUR DAYS POST-IMPLANT, THE ATRIAL PACING THRESHOLDS AND P-WAVE AMPLITUDES WERE UNABLE TO BE MEASURED, INDICATING LOSS OF CAPTURE. LEAD DISLODGEMENT WAS SUSPECTED. AN X-RAY WAS PERFORMED AND WAS COMPARED TO THE X-RAY TAKEN FOLLOWING THE IMPLANT PROCEDURE. THE LEAD TIP HAD NOT MOVED, BUT THERE WAS NO SLACK IN THE LEAD. IT WAS ALSO NOTED THAT THE PATIENT'S HEART HAD BECOME SIGNIFICANTLY ENLARGED. DURING THE REPOSITIONING PROCEDURE, THE ATRIAL PACING THRESHOLDS AND P-WAVES WERE STILL NOT ABLE TO BE MEASURED; HOWEVER, THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE PHYSICIAN BELIEVED THAT 100% PACING WITH A LOWER RATE LIMIT OF 90 BPM INDUCED HEART FAILURE, WHICH RESULTED IN THE INCREASED PACING THRESHOLDS AND SINUS NODE DYSFUNCTION. AFTER THE LEAD REVISION, THE DEVICE WAS REPROGRAMMED WITH A LOWER RATE LIMIT OF 60 BPM AND STEROIDS WERE ADMINISTERED TO THE PATIENT TO REDUCE THE INFLAMMATION. THE FOLLOWING DAY, THE SINUS NODE DYSFUNCTION WAS IMPROVED. ATRIAL LEAD MEASUREMENTS WERE ABLE TO BE TAKEN, WITH NORMAL THRESHOLDS AND P-WAVES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20979 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R