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

Model Number	RNS-300-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).- the rns system leads are placed in the frontal lobe.
Event or Problem Description
The treating clinician reported the patient was experiencing behavioral changes, specifically: vulgarity in conversations, irresponsibility, and lack of empathy.The changes in behavior corresponded with programming changes implemented on (b)(6) 2019 and were observed leading up to the (b)(6) clinic visit.Per the treating clinician, reduction of the programmed current resulted in a decrease in the behavioral changes.The physician will continue to titrate the rns neurostimulator settings.The patient is noted to have behavioral issues with his seizures, however the changes noted were not consistent with the patient's medical history.The patient's rns system leads are placed in the frontal lobe.

• 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: 8798425
• Report Number: 3004426659-2019-00028
• Device Sequence Number: 2839085
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017181223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: RNS-300-K
• Device Catalogue Number: 1007910
• Device Lot Number: 25858-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/17/2019
• 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: 54 YR