BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIUS SYSTEM

    MDR report key: 23711572 · Received December 3, 2025

    Report

    Report Number
    3026283936-2025-10021
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 7, 2025
    Report Date
    December 3, 2025
    Manufacturer
    NEUROS MEDICAL INC.
    Product Code
    SAZ
    UDI-DI
    00810118490002
    PMA / PMN Number
    P230020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PARTIAL REVISION FOR SUBJECT (B)(6) WAS ON (B)(6) 2024, WHILE INFECTION EVENT OCCURRED APPROXIMATELY 19 MONTHS LATER (11/05/2025). DUE TO THE LENGTH OF TIME BETWEEN REVISION AND INFECTION, IT IS HIGHLY UNLIKELY THAT THE INFECTION WAS RELATED TO THE DEVICE OR THE IMPLANT PROCEDURE; A RELATED INFECTION WOULD BE EXPECTED TO MANIFEST MORE ACUTELY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT PRESENTED TO EXPLANT THE IMPLANTABLE PULSE GENERATOR AND THE CUFF ELECTRODE LEAD FROM THE IMPLANT SITE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2846757 ALTIUS SYSTEM IMPLANTABLE PULSE GENERATOR SAZ NEUROS MEDICAL INC. FG-601-000 22071101 00810118490002

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Life Threatening| H| R