BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 24611622 · Received March 16, 2026

    Report

    Report Number
    3004426659-2026-00027
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 20, 2026
    Report Date
    March 16, 2026
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NEUROPACE WAS UNABLE TO IDENTIFY PATIENT NOR DEVICE DETAILS.

    Description of Event or Problem · 0

    ON 2/20/2026 NEUROPACE RECEIVED A VOLUNTARY MDR REPORT FROM THE FDA. THE FOLLOWING WAS REPORTED THROUGH THE VOLUNTARY REPORT[NS1.1] [RG1.2] [RG1.3] [NS1.4] (MW5182852). "A PATIENT'S REPRESENTATIVE CALLED.THE REASON FOR CALL WAS CALLER SAID THEY WANTED INFORMATION ON THE DBS SYSTEM FOR EPILEPSY.IN TALKING THEY SAID THE PATIENT HAD AN RNS AND VNS DEVICE THAT WAS NOT MANUFACTURED BY (B)(6).THEY SAID THEY HAD A BATTERY REPLACEMENT AND SOMETHING WENT WRONG AND THE PATIENT GOT AN INFECTION.PATIENT IS ON AN ANTIBIOTIC INDEFINITELY TO MAKE SURE THE INFECTION DOESN'T COME BACK.THEY HAD TO GO BACK IN AND CLEAN ALL THE INFECTION OUT.RNS IS GETTING LOW BATTERY.PATIENT HAS HAD SO MANY SURGERIES FOR THAT DEVICE THEY ARE NERVOUS ABOUT DOING YET ANOTHER SURGERY AND CREATING EVEN MORE SCAR TISSUE ON TOP OF SCAR TISSUE.THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)." A THOROUGH INVESTIGATION WAS CONDUCTED TO DETERMINE WHETHER THE REPORTED ADVERSE EVENT INVOLVED AN RNS SYSTEM PATIENT. BECAUSE NO IDENTIFYING DETAILS WERE INITIALLY PROVIDED, THE INVESTIGATION FOCUSED ON CONFIRMING (1) WHETHER THE INDIVIDUAL WAS AN RNS PATIENT, (2) THE PATIENT'S IDENTITY, AND (3) WHETHER AN RNS DEVICE WAS INVOLVED. TO COMPLETE THIS ASSESSMENT, THE TEAM PERFORMED A COMPREHENSIVE REVIEW THAT INCLUDED: · REVIEW OF THE INTERNAL PATIENT DATABASE TO IDENTIFY ANY PATIENTS WHO COULD PLAUSIBLY MATCH THE LIMITED INFORMATION PROVIDED. · SEARCH OF THE NPCE COMPLAINT DATABASE FOR ANY PRIOR OR RELATED REPORTS THAT COULD CORRELATE WITH THE EVENT. · CONSULTATION WITH THE FIELD TEAM, WHO EVALUATED THE REPORT DETAILS TO DETERMINE WHETHER THEY COULD RECOGNIZE OR IDENTIFY THE PATIENT BASED ON THEIR KNOWLEDGE OF THE LOCAL PATIENT POPULATION AND ACCOUNTS. DESPITE THIS EXTENSIVE REVIEW, NO PATIENT OR RNS DEVICE COULD BE CONCLUSIVELY IDENTIFIED BASED ON THE LIMITED INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667766 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-320-K UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown Other| R