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

Model Number	RNS 320
Medical Device Problem Codes	Failure to Interrogate (1332); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had her device placed in mri mode and then underwent an mri.Following the mri, the neurostimulator would not communicate with a programmer nor the remote monitor on (b)(6) 2023 the neurostimulator was replaced and returned to neuropace for investigation.
Additional Manufacturer Narrative
(b)(4).The explanted device was returned to neuropace and is undergoing analysis.
Additional Manufacturer Narrative
(b)(4) investigation this device experienced an externally impressed voltage during an mri procedure.The cinco 1e asic in this device went to a non-functional state wherein the internal regulated power supplies are stable at nearly zero volts.Cycling the power returned the device to normal operation.This is a known behavior of the cinco 1e asic.
Event or Problem Description
Original report- the patient had her device placed in mri mode and then underwent an mri.Following the mri, the neurostimulator would not communicate with a programmer nor the remote monitor.On (b)(6) 2023 the neurostimulator was replaced and returned to neuropace for investigation.

• 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: 18183483
• Report Number: 3004426659-2023-00058
• Device Sequence Number: 15352838
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190105
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS 320
• Device Catalogue Number: 1007694
• Device Lot Number: 25349-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Other
• Patient Age: 26 YR
• Patient Sex: Female