BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PR PACING LEAD

    MDR report key: 4080990 · Received August 22, 2014

    Report

    Report Number
    1035166-2014-00053
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    June 16, 2014
    Report Date
    August 21, 2014
    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) 2014, THE CUSTOMER REPORTED ADDITIONAL DETAILS WERE RECEIVED (ON (B)(6) 2014) OVER TWO YEARS AFTER THE INITIAL REPORTED OBSERVATIONS ((B)(6) 2012) CONFIRMING THAT THIS LEAD WAS REMOVED FROM SERVICE DUE TO THE CONTINUED OUT OF RANGE IMPEDANCE MEASUREMENTS (LESS THAN 200 OHMS). THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, THE REPORTED CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. NO OTHER ADVERSE EVENTS WERE REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 13 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508156 PR PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. 4017 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR