BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPRINT FIDELIS LEAD

    MDR report key: 20359257 · Received October 2, 2024

    Report

    Report Number
    MW5160460
    Event Type
    Other
    Date Received
    October 2, 2024
    Date of Event
    July 10, 2024
    Report Date
    October 2, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD [(B)(6) ICD] SINGLE CHAMBER DEFIBRILLATOR. HIS ONE AND ONLY LEAD WAS A MEDTRONIC 6949 SPRINT FIDELIS LEAD. PATIENT CAME TO ER ON (B)(6) 2024 HAVING OVERSENSING ON HIS MEDTRONIC RV LEAD, LEADING TO INAPPROPRIATE SHOCKS. PATIENT WAS BROUGHT INTO OPERATING ROOM, WHERE THE [(B)(6) ICD] WAS EXPLANTED AND REPLACED WITH A NEW [(B)(6) ICD] DUAL CHAMBER DEFIBRILLATOR. THE MEDTRONIC RV LEAD WAS CAPPED AND A NEW, [(B)(6) HV LEAD] LEAD WAS IMPLANTED IN ITS PLACE. PATIENT IS STABLE AND RECOVERING. 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
    693351 SPRINT FIDELIS LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown