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

Model Number RNS-320-K - FGI

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

Patient Problems Headache (1880); Intracranial Hemorrhage (1891); Pain (1994)

Event Date 08/11/2023

Event Type  Injury  

Event Description

A few months after implant the patient reported skull pain.Over the years he occasionally reported skull pain, headaches and more recently pain throughout his body.The patient was admitted for evaluation.The patient requested that the rns be removed.On (b)(6) 2023 the patient underwent a complete rns system explant (neurostimulator, leads, and burr hole covers).Treatment also included surgical evacuation.The doctor reported the patient suffered subdural hemorrhaging following the procedure.The patient was admitted to icu on (b)(6) 2023 for subdural hemorrhage following explant.He is currently intubated and has a feeding tube.The cause of the patient's pain was not determined.

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

Event Description

A few months after implant ((b)(6)) the patient reported skull pain.The patient continued to occasionally report skull pain and headaches for approximately five years post implant.More recently he reported pain throughout his body.In (b)(6) 2023, the patient was admitted for evaluation.The patient requested that the rns be removed.On (b)(6) 2023 the patient underwent a complete rns system explant (neurostimulator, leads, and burr hole covers).Treatment also included surgical evacuation.Prior to explant, the doctor reported that the patient had scarring around the subdural strip lead, there was no report of hemorrhaging.The doctor reported the patient suffered subdural hemorrhaging following the procedure.The patient was admitted to icu on (b)(6) 2023 for subdural hemorrhage following explant.The cause of the patient's pain was not determined.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 5108822607
• MDR Report Key: 17685884
• MDR Text Key: 322671168
• Report Number: 3004426659-2023-00044
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190402
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1007694
• Device Lot Number: 25944-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male