BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17522922 · Received August 12, 2023

    Report

    Report Number
    MW5129870
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    October 3, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO TECHNICAL SERVICES ON (B)(6) 2012 THAT THIS RA LEAD IS UNDER SENSING. PATIENT WITH AV NODE ABLATION IN 1992. CURRENTLY IN A FIB AGAIN AND PATIENT FEELS NOT VERY GOOD. UNDER SENSING P-WAVES AND NOT ATR MODE SWITCHING WITH SMALLER P-WAVES NOW. PREVIOUS ATRIAL SENSITIVITY SET TO 0.75MV. CAN'T TELL IF IN MODE SWITCH? LRL IS 60PPM, PACING AT 70PPM? IS THERE ATRIAL AUTO SENSITIVITY? PACING AT A LRL OF 70PPM IS A GOOD WAY TO TELL IF IN AN A TR. CHANGED SENSITIVITY TO 0.025MV TO SEE 0.50MV P-WAVES. NO ATRIAL AUTOSENSE. SENSING P-WAVES NOW AND MODE SWITCHING. 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
    870289 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5024M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown