BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY PACING LEAD

    MDR report key: 3240544 · Received July 16, 2013

    Report

    Report Number
    1035166-2013-00019
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 25, 2009
    Report Date
    July 12, 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. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. LOSS OF CAPTURE/SENSING 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

    ON (B)(6) 2013, THE CUSTOMER REPORTED THAT THIS ATRIAL LEAD WAS EXHIBITING CAPTURE AND SENSING ISSUES. A REVISION PROCEDURE WAS PERFORMED ((B)(6) 2013) AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ON (B)(6) 2013, THE CUSTOMER REPORTED THESE ISSUES WERE NOTED TO BE LOSS OF CAPTURE DESPITE MAXIMUM DEVICE OUTPUTS AND POSSIBLE OVERSENSING OF RESIDUAL ENERGY FROM VP DUE TO HIGHER RV SENSITIVITY SETTING. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 13 YEARS, 7 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330338 PY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY 44 PSBV 3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR