BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 17532818 · Received August 12, 2023

    Report

    Report Number
    MW5139725
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 1, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OJX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LV LEAD WAS IMPLANTED ON (B)(6) 2010. A CALL TO TECHNICAL SERVICES ON (B)(6) 2011 STATES THAT EPICARDIAL LEADS WERE IMPLANTED TODAY. ENDOCARDIAL LEADS WILL BE EXPLANTED IN 2-3 WKS (CALLER OR ASSOCIATE WILL CALL IN WHEN LEADS ARE EXPLANTED). THE 4965 IS THE RA LEAD, 5071 (094) IS THE RV LEAD, 5071 (097) IS THE LV LEAD. WHEN THE ENDOCARDIAL LEADS ARE EXPLANTED THE NEW EPICARDIAL LEADS WILL BE THE LEADS THAT WILL BE IN SERVICE. HISTORY IS THAT THE PATIENT WAS AV ABLATED FOR ATRIAL TACHYCARDIA AND A BIV PACER WAS IMPLANTED. PATIENT THEN HAD SYMPTOMS OF SWELLING IN THE FACE BECAUSE OF AN OCCLUDED SVC. MD DECIDED TO EXPLANT LEADS AND REPLACE THEM WITH EPICARDIAL LEAD SYSTEM. CURRENTLY THE NEW EPICARDIAL RA LEAD IS PLUGGED INTO THE DEVICE WITH THE OLD ENDO RA LEAD CAPPED. THE OLD ENDO RV LEAD IS STILL IN USE. THE NEW EPICARDIAL RV LEAD IS CURRENTLY PLUGGED INTO THE LV PORT. BOTH THE OLD ENDOCARDIAL AND NEW EPICARDIAL LV LEADS ARE CURRENTLY CAPPED. PATIENT WILL REMAIN IN THIS CONFIGURATION UNTIL THE ENDOCARDIAL LEADS ARE EXPLANTED. EP IS DR. (B)(6) . 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
    783799 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL 1258T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown