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

Model Number	CL-325-10-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The implant procedure was discontinued after the patient experienced a serious bleed.Any rns system product implanted was explanted at the time of the event.
Event or Problem Description
The patient underwent successful placement of an rns system depth lead during the initial implant procedure.However when attempting to open the dura for placement of a cortical strip lead, the patient experienced significant bleeding.The neurosurgeon abandoned the procedure and explanted the depth lead.A larger craniotomy was created to relieve pressure on the skin.Post-wound closure, the patient was sent for a ct scan.The neurosurgeon suspected a venous infarct, considering the patient has undergone previous cranial surgeries (not related to the rns system) which led to scar tissue and dural adhesions.As of (b)(6) 2021 the patient is reported to be very weak and aphasic.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 12389049
• Report Number: 3004426659-2021-00042
• Device Sequence Number: 3650644
• Product Code: PFN
• UDI-Device Identifier: 00855547005311
• UDI-Public: 010085554700531117240127
• 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: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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?: No
• Operator of Device: No Information
• Device Model Number: CL-325-10-K
• Device Catalogue Number: 1007933
• Device Lot Number: 30852-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR