BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 22495845 · Received July 14, 2025

    Report

    Report Number
    3004426659-2025-00044
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    July 3, 2025
    Report Date
    September 24, 2025
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) NEUROPACE IS PENDING RETURN OF THE EXPLANTED PRODUCT.

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION RESULTS - THIS DEVICE WAS SUBJECT TO SEVERE IMPACT FORCES AS EVIDENCED BY THE DEFORMED DEVICE CAN. THE TELEMETRY COIL EXHIBITED SIGNS OF PHYSICAL DAMAGE CONSISTENT WITH THE DEFORMATION OF THE DEVICE CASE. THE COIL WAS CONFIRMED TO BE OPEN. THIS IS CONSISTENT WITH THE DEVICE BECOMING NON-RESPONSIVE TO TELEMETRY. NO INFORMATION IS AVAILABLE CONCERNING THE SOURCE OF THE IMPACT THAT DAMAGED THIS DEVICE.

    Description of Event or Problem · 0

    THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2025 AND ALL RNS NEUROSTIMULATOR MEASUREMENTS WERE IN NORMAL RANGE FOR BATTERY AND IMPEDANCE. ON (B)(6) 2025 THE NEUROPACE FCE ATTENDED THE PATIENT CLINIC VISIT. THE RNS NEUROSTIMULATOR WAS UNRESPONSIVE TO INTERROGATION. THE LAST DOWNLOAD AND DATA TRANSFER WAS ON (B)(6) 2025. THE FCE CONFIRMED THE PATIENT HAD NOT HAD ANY FALLS, MEDICAL PROCEDURES, OR EXPOSURE TO ANY ELECTRICAL ACTIVITY SINCE (B)(6) 2025.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS REPORTED IN SECTION H10. ORIGINAL REPORT -THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2025 AND ALL RNS NEUROSTIMULATOR MEASUREMENTS WERE IN NORMAL RANGE FOR BATTERY AND IMPEDANCE. ON (B)(6) 2025 THE NEUROPACE FCE ATTENDED THE PATIENT CLINIC VISIT. THE RNS NEUROSTIMULATOR WAS UNRESPONSIVE TO INTERROGATION. THE LAST DOWNLOAD AND DATA TRANSFER WAS ON 06/03/2025. THE FCE CONFIRMED THE PATIENT HAD NOT HAD ANY FALLS, MEDICAL PROCEDURES, OR EXPOSURE TO ANY ELECTRICAL ACTIVITY SINCE (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395703 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-320-K 34417-1-1-1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Hospitalization| R| O