BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON LEAD

    MDR report key: 17534358 · Received August 12, 2023

    Report

    Report Number
    MW5141260
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    March 20, 2022
    Manufacturer
    UNKNOWN
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    VITATRON RV PACING LEAD NOISE WAS INHIBITING RV AND LV PACING IN THIS PACEMAKER DEPENDENT PATIENT. (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
    728020 VITATRON LEAD PERMANENT PACEMAKER ELECTRODE DTB UNKNOWN EXCELLENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown