BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 1213188 · Received October 23, 2008

    Report

    Report Number
    1035166-2008-00041
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    August 18, 2008
    Report Date
    October 20, 2008
    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 REPORTED ALLEGATION CANNOT BE CONFIRMED. 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 IN A DEVICE REPLACEMENT PROCEDURE FOR NORMAL DEPLETION, THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED (CAPPED) DUE TO THE HISTORICAL LOW IMPEDANCES. THIS RV LEAD HAD A DECREASE IN IMPEDANCE (144 OHMS). NEW PRODUCTS WERE SUCCESSFULLY IMPLANTED; NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 6 YEARS, 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCEW-IN PACING LEAD DTB OSCOR INC. 4017 4S12

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 1280| 523690