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

Model Number RNS-300-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

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 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
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, ca ; 2382788
• MDR Report Key: 10468663
• MDR Text Key: 204870919
• Report Number: 3004426659-2020-00037
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170830
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR