BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17526176 · Received August 12, 2023

    Report

    Report Number
    MW5133116
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    January 13, 2017
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RA LEAD WAS IMPLANTED ON (B)(6) 2015 AND REMAINS IMPLANTED AT THIS TIME. A CALL WAS PLACED TO TECHNICAL SERVICES ON (B)(6) 2016 STATING THAT THIS LEAD EXHIBITED OUT OF RANGE IMPEDANCE. THE PHYSICIAN WAS DR. MARUTHI GOTTIMUKKALA AT SENTARA NORFOLK GENERAL HOSPITAL IN NORFORLK, VA. NO OTHER INFORMATION IS AVAILABLE. 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
    565293 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown