BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR XL DR

    MDR report key: 22321909 · Received June 24, 2025

    Report

    Report Number
    2017865-2025-87899
    Event Type
    Death
    Date Received
    June 24, 2025
    Report Date
    October 20, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734501620
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION FOR H6 CODING.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS OF UNEXPECTED MODE SWITCH, DEVICE PROBLEM, AND ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM WERE NOT CONFIRMED. THE DEVICE WAS RECEIVED WITH BATTERY VOLTAGE ANT END OF SERVICE (EOS) LEVEL IN BACKUP MODE CONSISTENT WITH EXPOSURE TO COLD TEMPERATURE. DEVICE IMAGE INDICATES FALSE ERI WAS TRIGGERED CONSISTENT WITH LOW VOLTAGE FLUCTUATION. ELECTRICAL ANALYSIS PERFORMED AFTER REPLACING THE BATTERY INDICATED NORMAL FUNCTIONALITY. ADDITIONAL EVALUATION OF OUTPUT SIGNAL FOUND ALL PACING PARAMETERS WITHIN NORMAL RANGE. FURTHER INTERROGATION AT VARIOUS PULSE AMPLITUDES MEASURED CURRENT LEVELS WITHIN NORMAL RANGE. LONGEVITY ASSESSMENT WAS PERFORMED BASED ON FIELD SETTINGS AND THE DEVICE EXCEEDED PROJECTED LONGEVITY INDICATING NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOR AN UNKNOWN CAUSE. UPON DEVICE INTERROGATION, THE PACEMAKER WAS FOUND TO BE ON BACKUP MODE. THERE WERE CONCERNS IF THE DEVICE COULD HAD STOPPED WORKING. SINCE ELECTROCARDIOGRAMS WERE NOT ENABLED, A RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT'S DEATH COULD NOT BE ESTABLISHED. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063032 ZEPHYR XL DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5826 3294691 05414734501620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death