BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZY PACING LEAD

    MDR report key: 3190970 · Received June 19, 2013

    Report

    Report Number
    1035166-2013-00014
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 18, 2013
    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. A NEW ATRIAL LEAD WAS IMPLANTED WITHOUT FURTHER INCIDENT, AND NO ADVERSE PT EFFECTS WERE REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADD'L 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 LEAD WAS EXHIBITING NO CAPTURE DESPITE MAXIMUM DEVICE OUTPUTS (NO MEASUREMENTS WERE PROVIDED). REPOSITIONING OF THE LEAD WAS UNSUCCESSFUL AND THE LEAD COULD NOT BE MOVED. THEREFORE, THE LEAD WAS SURGICALLY ABANDONED (CAPPED) AND A NEW ATRIAL LEAD WAS IMPLANTED WITHOUT FURTHER INCIDENT. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 10 YEARS, 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278475 ZY PACING LEAD RETRACTABLE SCREW - IN PACING LEAD DTB OSCOR INC. ZY 44 PJUSBV 4S9

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR