BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3955939 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-14366
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING IMPEDANCES OF GREATER THAN 2000 OHMS ALONG WITH HIGH PACING THRESHOLD OF 4 VOLTS. THERE WAS NO NOISE REPORTED ON THE LEAD AND THIS PATIENT ATRIAL PACE LESS THAN 2% OF THE TIME. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS WITH BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT THEY CAN CONSIDER GETTING A CHEST X-RAY FOR THE PATIENT TO CHECK FOR ANYTHING GROSSLY WRONG WITH THE LEAD. TS ALSO DISCUSSED ATRIAL LEAD REVISION OR CONTINUE MONITORING IF ATRIAL LEAD SENSING WAS STILL GOOD. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE CAUSE WAS NOT DETERMINED. AT THIS TIME, THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433638 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR N118| 4518| 0148| 4524| H179| 4513| 4480