BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17520458 · Received August 12, 2023

    Report

    Report Number
    MW5127406
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    May 4, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CALL TO TECHNICAL SERVICES ON (B)(6) 2011 STATES THAT A MEDTRONIC EPICARDIAL LEAD WAS IMPLANTED ON (B)(6) 2011. IMPEDANCE DOWN FROM 1047 TO 547; THRESHOLD IS STABLE. TS CONTACTED MEDTRONIC TECHNICAL SERVICES WHO STATES LEAD IMPEDANCE RANGE IS 200-4000 OHMS. AS LONG AS IMPEDANCE IS IN RANGE, OTHER MEASUREMENTS STABLE, MEDTRONIC TS IMPLIES THERE'S NO CONCERN REGARDING LEAD. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868877 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 4965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown