BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZY PACING LEAD

    MDR report key: 2050044 · Received March 14, 2011

    Report

    Report Number
    1035166-2011-00010
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 8, 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), THEREFORE IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE REPORTED ALLEGATION CANNOT BE CONFIRMED. NO ADVERSE PATIENT EFFECTS WERE NOTED. 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 ON (B)(6), 2011, THAT THIS RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED (CAPPED) DUE TO HIGH THRESHOLD MEASUREMENTS (THE MEASUREMENTS WERE NOT PROVIDED TO THE CUSTOMER). NO ADVERSE PATIENT EFFECTS WERE NOTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 15 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. ZY 48 JUSBV 1M8

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR