BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 2050052 · Received March 14, 2011

    Report

    Report Number
    1035166-2011-00011
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 9, 2011
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED (CAPPED), THEREFORE IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. A REPLACEMENT LEAD WAS IMPLANTED WITHOUT FURTHER INCIDENT. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE HISTORY RECORDS AND THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THIS PATIENT WAS IN THE EMERGENCY ROOM AND SYSTEM EVALUATION NOTED THIS RIGHT VENTRICULAR LEAD WAS NOT CAPTURING AND WAS EXHIBITING ELEVATED THRESHOLD MEASUREMENTS (INCREASED TO 4.5V AT 1.0MS). THE PATIENT'S HEART RATE WAS IN THE 30'S. THE PHYSICIAN ELECTED TO REPLACE THIS LEAD (SURGICALLY ABANDONED, CAPPED) AND A REPLACEMENT LEAD WAS IMPLANTED WITHOUT FURTHER INCIDENT. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 10 YEARS, 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4017 3R2

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR