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

Model Number	DL-330-3.5-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Muscle Weakness/Atrophy (1967); Neuropathy (1983)
Date of Event	07/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.
Event or Problem Description
The patient self-reported that he was diagnosed with an intracranial hemorrhage.Neuropace has reached out to the emergency room physician multiple times with no response.Neuropace has reached out to the patient's treating epileptologist and is awaiting response from the treating epileptologist regarding further details.
Additional Manufacturer Narrative
(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.
Event or Problem Description
Original report - the patient self-reported that he was diagnosed with an intracranial hemorrhage.Neuropace has reached out to the emergency room physician multiple times with no response.Neuropace has reached out to the patient's treating epileptologist and is awaiting response from the treating epileptologist regarding further details.New information - additional details provided by the epileptologist - reported unwitnessed seizure (b)(6) 2023 that was "more intense than usual" sentara emergency department evaluated the patient on (b)(6) 2023.The patient reported progressive weakness of right leg and foot, milder but progressive weakness of right arm.The patient underwent extended hospitalization.This was diagnosed as an intraparenchymal hemorrhage.

• 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: 17567342
• Report Number: 3004426659-2023-00038
• Device Sequence Number: 20499462
• Product Code: PFN
• UDI-Device Identifier: 00855547005038
• UDI-Public: 010085554700503817210213
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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?: No
• Device Model Number: DL-330-3.5-K
• Device Catalogue Number: 1007604
• Device Lot Number: 19984-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 08/30/2023
• 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: Other
• Patient Age: 33 YR
• Patient Sex: Male