BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT SR

    MDR report key: 23860294 · Received December 21, 2025

    Report

    Report Number
    2017865-2025-1007747
    Event Type
    Death
    Date Received
    December 21, 2025
    Date of Event
    August 12, 2024
    Report Date
    January 23, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RECEIVED FROM THE FIELD WITH BATTERY VOLTAGE BELOW END OF SERVICE LEVEL (EOS). VISUAL INSPECTION FOUND NO ANOMALY ON THE HEADER RELATED TO THE FIELD CONCERN. ANALYSIS OF THE DEVICE IMAGE INDICATED DEVICE WAS WITHIN NORMAL RANGE OF OPERATION. LONGEVITY ASSESSMENT WAS PERFORMED BASED ON FIELD SETTINGS, AND THE DEVICE MEET PROJECTED LONGEVITY INDICATING NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2024 DUE TO NON-RHEUMATIC AORTIC VALVE DISORDER. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532213 ACCENT SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM1110 3436633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death