BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR XL DR

    MDR report key: 22091141 · Received May 27, 2025

    Report

    Report Number
    2017865-2025-64793
    Event Type
    Death
    Date Received
    May 27, 2025
    Date of Event
    February 20, 2011
    Report Date
    August 18, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 AND B2 - "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)" WAS INCORRECTLY SELECTED IN PREVIOUS REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAD NO TELEMETRY AND BATTERY AT END OF SERVICE (EOS) LEVEL UPON RECEIPT. DEVICE IMAGE COULD NOT BE SAVED, AND DATA TREND COULD NOT BE PLOTTED DUE TO LACK OF DEVICE IMAGE. THE DEVICE WAS EVALUATED UNDER NOMINAL CONDITIONS, AFTER REPLACING THE BATTERY, AND RESULTS INDICATED NORMAL FUNCTIONALITY. FURTHER ANALYSIS AT VARIOUS PULSE AMPLITUDE FOUND NORMAL CURRENT AND VOLTAGE LEVEL. LONGEVITY ASSESSMENT COULD NOT BE PERFORMED BECAUSE DEVICE IMAGE COULD NOT BE SAVED AND THERE WERE NO OTHER SOURCE OF INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PULSE GENERATOR AND RIGHT VENTRICULAR (RV), AND RIGHT ATRIAL (RA) LEADS WERE EXTRACTED DUE TO PATIENT DEATH. THE IMMEDIATE CAUSE OF DEATH WAS INDICATED AS CARDIAC INSUFFICIENCY. THERE WAS NO ALLEGATION OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729128 ZEPHYR XL DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5826 0002147849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| D