BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC, INC.

    MDR report key: 21471181 · Received February 26, 2025

    Report

    Report Number
    MW5166878
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 19, 2025
    Report Date
    February 21, 2025
    Manufacturer
    SPRINT QUATTRO SECURE MRI SURESCAN LEAD
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF P-WAVE AND INTERMITTENT LOSS OF CAPTURE. THE PACE/ SENSE PORTION OF THE LEAD WAS UNPLUGGED AND CAPPED. IT WAS REPLACED WITH AN EXISTING PACE/ SENSE LEAD THAT WAS USED PRIOR TO THE DEVICE UPGRADE FROM PACEMAKER TO ICD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WELL AND REMAINED IN STABLE CONDITION. 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
    1027349 MEDTRONIC, INC. PERMANENT DEFIBRILLATOR ELECTRODES NVY SPRINT QUATTRO SECURE MRI SURESCAN LEAD 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown