BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 17535297 · Received August 12, 2023

    Report

    Report Number
    MW5142196
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 1, 2020
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    OJX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    HIGH LEH VENTRICULAR (LV) OUTPUT REVIEW OF THE LV LEAD IMPEDANCE SUGGESTS THAT THE IMPEDANCE IS DECREASING. THIS IS MOST LIKELY THE REASON FOR THE HIGH LV OUTPUT (THRESHOLD). (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
    1354571 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX BOSTON SCIENTIFIC 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown