BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXION PACING LEAD

    MDR report key: 1983337 · Received February 4, 2011

    Report

    Report Number
    1035166-2011-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 2, 2011
    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), AND REPLACED WITH NO ADVERSE PT EFFECTS REPORTED; THEREFORE, IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. THE EVENT WILL BE R-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 THAT THIS RIGHT VENTRICULAR LEAD HAD SUSTAINED INSULATION DAMAGE. THEREFORE, THE LEAD WAS REMOVED FROM SERVICE (SURGICALLY ABANDONED, CAPPED) AND REPLACED. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 8 YEARS, 11 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 1T1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR