BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 1912992 · Received November 18, 2010

    Report

    Report Number
    1035166-2010-00064
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 18, 2010
    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. THIS LEAD WAS SUCCESSFULLY REPLACED WITH A NEW LEAD AND NO ADVERSE PT EFFECTS WERE OBSERVED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFO 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 ATRIAL LEAD WAS SURGICALLY ABANDONED (CAPPED) DUE TO LOW P-WAVE MEASUREMENTS AND PACING IMPEDANCE MEASUREMENTS (NO SPECIFIC MEASUREMENTS WERE REPORTED). THIS LEAD WAS SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADVERSE PT EFFECTS WERE OBSERVED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 9 YRS, 1 MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4016 3S5

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR