BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 2800159 · Received October 12, 2012

    Report

    Report Number
    1035166-2012-00026
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 14, 2012
    Report Date
    October 11, 2012
    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. 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

    ON (B)(6) 2012, THE CUSTOMER REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING WITH PACING INHIBITION FOR LESS THAN 2 CONSECUTIVE SECONDS. THE PATIENT REPORTED SYMPTOMS OF BEING LIGHTHEADED AND PRE-SYNCOPE, BUT DID NOT LOOSE CONSCIOUSNESS. THE PATIENT IS NOT PACER DEPENDENT, BUT HAS A VERY SLOW UNDERLYING RHYTHM, A LEAD REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. DURING THE PROCEDURE THE PHYSICIAN HAD EXPERIENCED DIFFICULTY REMOVING THE LEAD FROM THE HEADER OF THE DEVICE. ONCE THE LEAD WAS REMOVED, ON PROXIMAL RING OF TERMINAL PIN, THE SETSCREW HAD MADE A DIMPLE IN METAL WHICH COULD VISIBLY BE SEEN. A NEW LEAD WAS IMPLANTED SUCCESSFULLY WITH NO FURTHER ISSUE OF OVERSENSING OBSERVED. THERE WERE NO ADDITIONAL PATIENT EFFECTS REPORTED. THE CHRONIC LEAD WAS SURGICALLY ABANDONED (CAPPED) AND WILL NOT BE RETURNED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 10 YEARS, 10 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXION PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4018 1S8

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR