BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 1213189 · Received October 20, 2008

    Report

    Report Number
    1035166-2008-00042
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 15, 2001
    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 ATRIAL LEAD WAS EXTRACTED AND DISCARDED (DAMAGED DURING EXTRACTION PROCEDURE), 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. THRESHOLD ELEVATION IS A RECOGNIZED CLINICAL EVENT REFERENCED 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 AT A RECENT PACEMAKER REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, THE PHYSICIAN REMOVED THIS RIGHT ATRIAL LEAD AND A COMPETITOR'S RIGHT VENTRICULAR LEAD, DUE TO INCREASING THRESHOLD MEASUREMENTS. THE ATRIAL LEAD WAS EXTRACTED AND DISCARDED (IT WAS DAMAGED DURING THE EXTRACTION PROCESS). A NEW PACING SYSTEM WAS SUCCESSFULLY IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ATRIAL LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 6 YEARS, 9 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4016 3S6

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR