BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LV LEAD

    MDR report key: 23276153 · Received October 14, 2025

    Report

    Report Number
    MW5177268
    Event Type
    Malfunction
    Date Received
    October 14, 2025
    Report Date
    September 22, 2025
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR ASSISTANCE WITH PROGRAMMING THIS SYSTEM INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TECHNICAL SERVICES (TS) INFORMED THIS IS A NON-CONDITIONAL SYSTEM AS THE DEVICE AND RIGHT ATRIAL (RA) LEAD WERE NON-BIOTRONIK PRODUCTS AND PROGRAMMED THE SYSTEM. AFTER THE MRI WAS PERFORMED, THIS SYSTEM WAS REMOVED FROM THE MRI PROTECTION MODE, IT WAS CONFIRMED THAT ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS AND WAS FUNCTIONING AS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE. 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
    175530 LV LEAD DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX BIOTRONIK, INC. 406079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown