BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2780418 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12527
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE DEVICE REPLACEMENT PROCEDURE, THIS ATRIAL LEAD WAS EXHIBITING ELEVATED THRESHOLD MEASUREMENTS AND NOISE. ADDITIONALLY, IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS WHEN INSERTED INTO THE ATRIAL AND VENTRICULAR PORTS OF THE REPLACEMENT DEVICE. THE PHYSICIAN SUSPECTED AN ISSUE WITH THIS DEVICE AND DECIDED TO USE ANOTHER DEVICE. HOWEVER, MEASUREMENTS WERE UNREMARKABLE FOR ANY IMPROVEMENT. IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS WITH THE PACING SYSTEM ANALYZER (PSA). THE LEAD INSULATION WAS REPAIRED WITH A REPAIR KIT AND CARDIAC TISSUE AND/OR BODY FLUIDS WERE CLEANED OFF OF THE TERMINAL PIN AND THEN NORMAL IMPEDANCE MEASUREMENTS WERE OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 4088| 4087| 1298