BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 1833307 · Received September 9, 2010

    Report

    Report Number
    1035166-2010-00051
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    July 19, 2010
    Report Date
    September 9, 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. THE EVENT WILL BE RE-EVALUATED IF ADD'L INFO BECOMES AVAILABLE. THRESHOLD ELEVATION IS A RECOGNIZED CLINICAL EVENT REFERENCE IN THE DEVICE'S LABELING AND/OR REPORTED IN THE MEDICAL LITERATURE. 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 THRESHOLD MEASUREMENTS GREATER THAN 3.5 V/1.0 MS. IMPEDANCE MEASUREMENTS WERE ALSO LOW AROUND 290 OHMS AND R-WAVES WERE MEASURED AT 3.6 MV. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 6 YRS, 5 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 2T3

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR