BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17533402 · Received August 12, 2023

    Report

    Report Number
    MW5140306
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 1, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    OS-(B)(6) 2020 03:00:06 A.UNIPOLAR LEAD IMPEDANCE 190 OHMS. L4-(B)(6) 2020 03:00:12. "A. UNIPOLAR LEAD IMPEDANCE 190 OHMS. OS-(B)(6) 2020 03:00:12 A. UNIPOLAR LEAD IMPEDANCE 190 OHMS. (B)(6)2020 03:00:0S A.UNIPOLAR LEAD IMPEDANCE 190 OHMS. THE IMPEDANCE VALIDATION THRESHOLD FOR THE RVTIP-CAN IS 1400 OHMS. THE IMPEDANCE VALIDATION THRESHOLD FOR THE RVRING-CAN IN 494 OHMS. (B)(4). 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
    1216698 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL 188TC 1688TC52

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown