BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIUS SYSTEM

    MDR report key: 21754069 · Received April 2, 2025

    Report

    Report Number
    3026283936-2025-00008
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 9, 2025
    Report Date
    April 1, 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 A MECHANICAL BREAK OF THE NERVE CUFF ELECTRODE (LEAD) IS THE MOST LIKELY CAUSE. 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR AND LEAD FOR PAIN MANAGEMENT CAUSED BY BKA/AKA AMPUTATION. IT WAS REPORTED THAT THEIR DEVICE WAS SHOCKING THEM. THE PATIENT ALSO EXPERIENCED PAIN AND DISCOMFORT AS A RESULT OF THE SHOCK. THIS PATIENT WAS ENROLLED IN THE QUEST TRIAL, NOW COMPLETED, AND CONTACTED THE HEALTH CARE FACILITY BY PHONE TO REPORT THESE ISSUES. THE SHOCKING SENSATION APPEARS TO BE INTERMITTENT. IMPEDANCE WAS MEASURED TO BE HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688143 ALTIUS SYSTEM NERVE CUFF ELECTRODE LGW NEUROS MEDICAL INC. FG-602-003

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other