BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PY PACING LEAD

    MDR report key: 3932291 · Received April 4, 2014

    Report

    Report Number
    1035166-2014-00026
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    January 31, 2014
    Report Date
    April 3, 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 CAPPED AND ABANDONED, THEREFORE, IT WILL NOT BE RETURNED FOR ANALYSIS. AS A RESULT, THE ALLEGATIONS AGAINST THIS LEAD CANNOT BE CONFIRMED. NO ADVERSE PT EFFECTS WERE REPORTED. THE EVENT WILL BE RE-EVALUATED IF ADD'L INFO 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) 2014, THE CUSTOMER REPORTED THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUT. HOWEVER, THERE WAS NO EPISODE OF ASYSTOLE NOTED. THE RV LEAD WAS CAPPED AND ABANDONED. THE DEVICE WAS EXPLANTED AND WAS KEPT IN THE HOSP. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROXIMATELY 14 YEARS, 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205291 PY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY58 PSBV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR