BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 22216276 · Received June 16, 2025

    Report

    Report Number
    3004426659-2025-00037
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 26, 2025
    Report Date
    June 16, 2025
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005359
    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). THE EXPLANTED PRODUCT WAS NOT RETURNED TO NEUROPACE FOR ANALYSIS. THE ECOG AND IMPEDANCE DATA ARE SUGGESTIVE OF A POTENTIAL LEAD BREAK.

    Description of Event or Problem · 0

    ARTIFACT SIGNAL WAS OBSERVED ON THE PATIENT ECOG AROUND (B)(6) 2024. HIGH IMPEDANCE WAS ALSO OBSERVED ON THE LEFT THALAMUS CENTRAL MEDIAN (LCM) LEAD CONTACT 1 AND 2. A PROGRAMMING CHANGE WAS MADE ON (B)(6) 2024 TO DISABLE STIMULATION ON THE LCM LEAD. THE LEAD WAS REPLACED ON (B)(6) 2025. DAMAGE WAS OBSERVED ON THE EXPLANTED LEAD JUST DISTAL OF THE ENTRY POINT INTO THE SKULL/ PROTECTIVE SLEEVE. THE LEAD HAD BEEN SECURED WITH A DOG BONE WITH LEAD PROTECTION. THERE WAS NO REPORTED FALL OR TRAUMA WHICH COULD HAVE CONTRIBUTED TO THE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502729 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. DL-344-3.5-K 33831-1-1-1 00855547005359

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Hospitalization| O