BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17520326 · Received August 12, 2023

    Report

    Report Number
    MW5127274
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    August 31, 2011
    Report Date
    October 6, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RA LEAD WAS IMPLANTED ON (B)(6) 2011. A CALL TO TECHNICAL SERVICES ON (B)(6) 2011 STATES THAT ON PRESENTING THEY ARE SEEING LNH-LV. IT IS EITHER OVERSENSING THE RA (WHICH IS WHAT DR. BERGER THINKS IS HAPPENING) OR IT IS A TRUE LV THAT IS OCCURRING. EXPLAINED HOW LVPP WORKS, CAN SHORTEN TO 300, CAN CHANGE SENSING VECTOR ON THE LV TO SEE IF THEY CAN PROGRAM AROUND. IF THEY ARE NOT ABLE TO PROGRAM AROUND, CAN TURN OFF SENSING ON LV, BUT THIS WOULD BE CONSIDERED OFF LABEL. 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
    2176843 UNKNOWN PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL 1888TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown