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	Intracranial Hemorrhage (1891); Paresis (1998)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the rns system remains implanted and programmed for use.
Event or Problem Description
The patient underwent implantation with the rns system on (b)(6) 2021.Immediately post-implant, the patient was not able to move his contralateral side.Symptoms started as distal left hand weakness that progressed to involve the left arm and leg.A postop ct was performed and indicated a hemorrhage near the location of the leads (approximately 1cm away), located in the motor cortex.The surgeon hypothesized that the bleed may have been due a vessel which ruptured from the pressure of the implanted leads after surgical closure.No surgical intervention was necessary and by the evening after surgery, the patient demonstrated improvement in arm movement.Multiple post-op cts were taken and no changes were seen in the size/location of the bleed.The patient was subsequently discharged from the hospital.

• 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: 11346626
• Report Number: 3004426659-2021-00004
• Device Sequence Number: 14100859
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917220822
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: 1007609
• Device Lot Number: 28804-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/18/2021
• 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: Hospitalization
• Patient Age: 26 YR