MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number	RM, 5107,
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Fire (1245)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685); Full thickness (Third Degree) Burn (2696)
Date of Event	01/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the remote monitor was returned to neuropace and is undergoing investigation.
Event or Problem Description
On (b)(6) 2026, the patient's mother reported that the patient's remote monitor ignited at approximately 9:40 pm on (b)(6) 2025.According to her account, the patient was interrogating his neurostimulator with the trm (sn (b)(6).During that time the mother reported the trm initially displayed its normal screen, but then started glowing orange, actively burning, and producing smoke.The mother reported that the patient had experienced a seizure prior to her noticing the fire.She immediately knocked the device away causing it to fall to the floor.At the time of the event, the trm was not connected to its power adapter.The patient sustained third-degree burns to his left palm and right fingertips, as well as a first-degree burn to his right arm above the elbow.He was evaluated and treated by his physician but did not require hospitalization.
Additional Manufacturer Narrative
(b)(4).The remote monitor was returned and investigated by neuropace and an external engineering laboratory.Neuropace outsourced the investigation of the remote monitor to exponent, an engineering laboratory that provides expertise in medical device failure analysis and definitive, science-based answers, the work associated with investigation.Exponent determined that the cause of the battery thermal runaway event was likely to be major mechanical damage to the tablet housing caused by large external forces.The root cause of this mechanical damage remains unknown and was not reported by the patient; however, exemplar testing shows that the mechanical damage was not likely to be caused by thermal factors, was not consistent with a drop or throw event, and required a substantial amount of force to be applied to the tablet not consistent with reasonably foreseeable misuse.Additionally, and specifically, the battery thermal runaway event was very unlikely to have arisen spontaneously due to intrinsic battery failure or battery quality issues.The root cause of the burns to the patient was direct contact with the unit.
Event or Problem Description
Investigation results, refer to section h10 additional information: the thermal event resulted in the patient sustaining burns to their left palm, right fingertips, and right arm above the elbow.We noted a discrepancy in the information obtained relating to the patient.The fda report submitted by the physician (mw5182362) reported the patient sustained superficial (first degree) burns.Npce was informed by the mother that the patient sustained third-degree burns to left palm and right fingertips and a first-degree burn to right arm above the elbow.The initial mdr reported by neuropace, included the information as reported by the mother (as third-degree burn to left palm and right fingertips and first-degree burn to right arm above the elbow).Original report on (b)(6) 2026, the patient's mother reported that the patient's remote monitor ignited at approximately 9:40 pm on (b)(6) 2025.According to her account, the patient was interrogating his neurostimulator with the trm (sn (b)(6)).During that time the mother reported the trm initially displayed its normal screen, but then started glowing orange, actively burning, and producing smoke.The mother reported that the patient had experienced a seizure prior to her noticing the fire.She immediately knocked the device away causing it to fall to the floor.At the time of the event, the trm was not connected to its power adapter.The patient sustained third-degree burns to his left palm and right fingertips, as well as a first-degree burn to his right arm above the elbow.He was evaluated and treated by his physician but did not require hospitalization.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 5108822607
• MDR Report Key: 24104387
• Report Number: 3004426659-2026-00007
• Device Sequence Number: 10259979
• Product Code: PFN
• UDI-Device Identifier: 00855547005427
• UDI-Public: 0100855547005427
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: RM, 5107,
• Device Catalogue Number: 1008449
• Device Lot Number: 35084-1-1-1
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Life Threatening
• Patient Age: 43 YR
• Patient Sex: Male