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	Fall (1848)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
During a routine follow-up, the patient reported having issues in the last couple of months with interrogating at home.Multiple attempts were made to interrogate the device using different programmers and wands, all attempts were unsuccessful.The rns provided no signal when attempting to interrogate.The device appears to be nonfunctional.The patient's mother reported that the patient had a fall in (b)(6) or (b)(6) 2022, resulting in the patient hitting his head on a wall.The patient did not go to the hospital, nor have any imaging or surgery after the fall.The rns was replaced on 08 nov 2022.

• 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 ; 6502382788
• MDR Report Key: 16559874
• Report Number: 3004426659-2023-00012
• Device Sequence Number: 17498572
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717201001
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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: 29298-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Other
• Patient Age: 27 YR
• Patient Sex: Male