BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 21494024 · Received February 28, 2025

    Report

    Report Number
    MW5167083
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Report Date
    January 14, 2025
    Manufacturer
    PACESETTER/ ABBOTT MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIA I (RA) LEAD BOTH EXHIBITED NOISE, WITH ATRIAL OVERSENSING AND PACING INHIBITION. IT WAS NOTED THAT BOTH LEADS WERE IMPLANTED IN 1994, AND PACE IMPEDANCE MEASUREMENTS WERE IN THE LOW 200S OHMS RANGE FOR BOTH LEADS. ADDITIONALLY, THE RV LEAD WAS SET TO 10 MV, AND LIKELY HAD BEEN FOR QUITE SOME TIME. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS, AND RECOMMENDED LEAD EVALUATION TO CONFIRM THRESHOLD AND IMPEDANCE MEASUREMENTS WERE STABLE BEFORE MAKING ANY PROGRAMMING CHANGES. THE RV AND RA LEADS REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DISCLAIMER STATEMENT: 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
    1331164 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB PACESETTER/ ABBOTT MEDICAL 1023M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown