BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 22146798 · Received June 4, 2025

    Report

    Report Number
    3004426659-2025-00032
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    April 18, 2025
    Report Date
    June 4, 2025
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005366
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE EXPLANTED PRODUCT WAS NOT RETURNED TO NEUROPACE FOR ANALYSIS.

    Description of Event or Problem · 0

    IN (B)(6) 2025, NPE RECEIVED CLINICAL NOTES FROM THE TREATING CENTER REGARDING A (B)(6) 2024 VISIT. THE NOTES INDICATED THAT THE PATIENT HAD REPORTED A PERSISTENT RIGHT-SIDED HEADACHE AND A SHARP STABBING PAIN ALONG HER RIGHT TEMPOROPARIETAL SKULL. THE PAIN WAS NEAR THE RNS NEUROSTIMULATOR SITE. THE SKIN WAS NOTED TO BE INTACT AND NO INFECTION WAS OBSERVED. THERE WAS NO EVIDENCE OF PROTRUSION. THE PATIENT REPORTED THAT THE PAIN WAS INTOLERABLE AND CONSTANT. THE PATIENT WAS TREATED TEMPORARILY WITH PAIN RELIEVING MEDICATIONS. A FOLLOW UP VISIT IN (B)(6) 2025 REPORTED ON SEIZURE REDUCTION AND QUALITY OF LIFE, THE CLINICAL NOTES DID NOT REFERENCE FURTHER PAIN ASSESSMENT. AT THE PATIENT'S REQUEST, THE RNS SYSTEM WAS EXPLANTED (THE NEUROSTIMULATOR AND TWO DEPTH LEADS) ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591876 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-320-K 33372-1-1-1 00855547005366

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other| H