BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIUS SYSTEM

    MDR report key: 22302807 · Received June 20, 2025

    Report

    Report Number
    3026283936-2025-10005
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    January 1, 2025
    Report Date
    June 19, 2025
    Manufacturer
    NEUROS MEDICAL INC.
    Product Code
    LGW
    PMA / PMN Number
    P230020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE PRODUCT WILL NOT BE RETURNED AT THIS TIME FOR INVESTIGATION, IMPEDANCE MEASUREMENTS, REPORTED PATIENT SYMPTOMS AND HISTORICAL DEVICE KNOWLEDGE SUGGEST THAT THE INTEGRITY OF THE NERVE CUFF ELECTRODE (LEAD) MAY HAVE BEEN COMPROMISED DUE TO THE FALL CAUSING INTERMITTENT CONTINUITY AND A SHOCKING SENSATION. THE SHOCKING SEQUELA HAS SUBSEQUENTLY RESOLVED. THE NERVE CUFF ELECTRODE (LEAD) INVOLVED IN THIS EVENT, WAS UTILIZED UNDER IDE (B)(4); (SUBJECT OF THE QUEST CLINICAL STUDY) AND IS NOT THE APPROVED ALTIUS SYSTEM NERVE CUFF ELECTRODE (P230020/08-26-2024). NEUROS IS SUBMITTING THIS REPORT IN COMPLIANCE WITH FDA MEDICAL DEVICE REPORTING REGULATIONS UNDER 21 CFR PART 803.

    Description of Event or Problem · 0

    DURING 31-010'S IPG UPGRADE VISIT, SHE MENTIONED EXPERIENCING SHOCKING SENSATIONS A HANDFUL OF TIMES. SHE STATED THAT THEY BEGAN NOT LONG AFTER SHE FELL DOWN IN (B)(6) 2024 (THIS AE WAS REPORTED.) THE FALL RESULTED IN A BRUISE THAT STARTED FROM HER BACK AND ENDED RIGHT NEXT TO THE IPG. THE SHOCKING SENSATIONS ORIGINATED AT OR NEAR THE IPG AND TRAVEL DOWN HER STUMP. AS PART OF THE IPG UPGRADE VISIT, THE NEUROS FCS MEASURED THE DEVICE'S IMPEDANCE AND PERFORMED THRESHOLD TESTING. IMPEDANCE VALUES FLUCTUATED FROM 400 TO HIGH IMPEDANCE, BUT THEY WERE CONSISTENT WITH THOSE FROM PREVIOUS VISITS. THRESHOLD TESTING WAS ALSO CONSISTENT WITH PREVIOUS VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431358 ALTIUS SYSTEM NERVE CUFF ELECTRODE LGW NEUROS MEDICAL INC. FG-602-003

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other