BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 17523392 · Received August 12, 2023

    Report

    Report Number
    MW5130340
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 17, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OJX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    POSSIBLE HIGH LEH VENTRICULAR (LV) LEAD THRESHOLDS ON (B)(6) 2020. (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
    2193036 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL 1458Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown