BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIUS SYSTEM

    MDR report key: 25179137 · Received May 14, 2026

    Report

    Report Number
    3026283936-2026-30014
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 14, 2026
    Manufacturer
    NEUROS MEDICAL INC.
    Product Code
    SAZ
    UDI-DI
    00810118490088
    PMA / PMN Number
    P230020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POST RECOVERY, THE PATIENT ALONG WITH THEIR HCP DETERMINED THAT THE BEST TREATMENT OPTION WOULD BE TO EXPLANT THE SYSTEM. THE ALTIUS SYSTEM INCLUDING THE IPG AND NERVE CUFF ELECTRODES WERE EXPLANTED ON (B)(6) 2026. INTEROPERATIVE ASSESSMENT OF THE ALTIUS SYSTEM DURING THE EXPLANT PROCEDURE CONFIRMED THE SYSTEM WAS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 0

    ON 16APR2026, THE HEALTH CARE PROFESSIONAL (HCP) NOTIFIED NEUROS OF A POSSIBLE INFECTION THAT WAS LATER CONFIRMED ON (B)(6) 2026 AND ON (B)(6) 2026 A PROCEDURE TO TREAT THE IPG POCKET INFECTION WAS PERFORMED. THE PATIENT WAS HOSPITALIZED AND FITTED WITH A NEGATIVE PRESSURE WOUND THERAPY DEVICE (WOUND VAC) AND SENT TO RECOVERY AND SUBSEQUENTLY DISCHARGED ON (B)(6) 2026. ON (B)(6) 2026 - PATIENT VISITED THE ER WITH REPORTS OF A FEVER (102F), REDNESS AND SWELLING AROUND HIP (COUNTER INCISION) AND IPG INCISION, COLD SWEATS, AND CHILLS. ER PRESCRIBED ORAL ANTIBIOTICS (4000 MG CEPHALEXIN, 750 MG LEVOFLOXACIN). PATIENT WAS DISCHARGED SAME-DAY. (B)96) 2026 - NEUROS FOLLOWED UP WITH PATIENT REGARDING ER VISIT. PATIENT REPORTED THAT FEVER AND REDNESS HAVE SUBSIDED WITH SOME PERSISTENT SWELLING AT INCISION SITES AND THAT THEY ARE STILL USING THE ALTIUS SYSTEM. ON (B)(6) 2026 - NEUROS WAS NOTIFIED THAT PATIENT'S INFECTION WAS RESOLVED BUT SWELLING AT INCISION SITE AND IPG WAS STILL PRESENT. PATIENT OPTED FOR IPG EXPLANT. ON (B)(6) 2026 - THE ALTIUS SYSTEM INCLUDING THE IPG AND NERVE CUFF ELECTRODES WERE EXPLANTED. EXPLANT OF THE CUFF ELECTRODE, SUBJECT OF THIS REPORT, DID NOT INDICATE THE PRESENCE OF INFECTION, HOWEVER BECAUSE THE CUFF ELECTRODE IS ATTACHED TO THE IPG VIA AN IS-1 CONNECTION PORT, THE POSSIBILITY OF INFECTION CANNOT BE RULED OUT. INTEROPERATIVE ASSESSMENT OF THE ALTIUS SYSTEM DURING THE EXPLANT PROCEDURE CONFIRMED THE SYSTEM WAS FUNCTIONING AS INTENDED. AS OF 11MAY2026, THE PATIENT IS CURRENTLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27459 ALTIUS SYSTEM CUFF ELECTRODE SAZ NEUROS MEDICAL INC. FG-600-002 00810118490088

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Required Intervention| H