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 Problem Convulsion/Seizure (4406)

Event Date 07/17/2023

Event Type  Injury  

Event Description

Prior to implant, this patient was having 3-4 seizures per year.Immediately following the rns implant, the patient began experiencing an increase in seizures and was admitted to the hospital.A detection change was made during their initial stay but didn't turn on stimulation until the one-month follow-up post-op.Since then, the patient has been progressively getting worse, he has had three total clinic visits and at last visit was experiencing 10+ seizures per day according to the patient's mother.The ct scans all looked fine.The doctor's running theory is some mechanical influence of the physical device led to increased seizures, regardless of stimulation.They are familiar with the implant effect and how this is typically not what we see.The rns and leads were explanted on (b)(6) 2023.The seizures reportedly decreased immediately after explant.

Manufacturer Narrative

(b)(4).The returned device was investigated.There was no evidence of damage and the device performed as expected.There is no evidence of malfunction or device failure.

• 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: 17515792
• MDR Text Key: 321039718
• Report Number: 3004426659-2023-00036
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617230805
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1008191
• Device Lot Number: 32818-1-1-1
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 17 YR
• Patient Sex: Male