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 Codes	Emotional Changes (1831); No Code Available (3191)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Regarding the event date : note that per the site's irb policies, they are not allowed to provide the specific month/day that the event occurred.However the site has confirmed that the event did occur after rns system implant and that the year is correct.
Event or Problem Description
During review of adverse event data for an investigator initiated retrospective data collection study, a serious adverse event was identified that had not previously been reported to neuropace.The event, reported as related or possibly related to rns system neurostimulation, involved the patient developing suicidal ideation requiring hospitalization.The patient's vns therapy system was turned off 5 months prior to initial implant of the rns system.The patient underwent placement of the rns system without complication.Two days after rns system responsive stimulation was enabled, he developed suicidal ideation requiring hospitalization.The treating clinician enabled the patient's vns therapy system and with both the rns system and vns therapy systems enabled it was reported that the patient's condition improved.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• MDR Report Key: 10468663
• Report Number: 3004426659-2020-00037
• Device Sequence Number: 3257114
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: RNS-300-K
• Device Catalogue Number: 1007603
• Device Lot Number: 23277-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/28/2020
• 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: 30 YR