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

Model Number RNS-320-K - FGI

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2023

Event Type  Injury  

Event Description

During review of the patient ecog data it was observed that the neurostimulator battery voltage had fallen from 3.0v on (b)(6) 2023, to 2.72v on (b)(6) 2023, and most recently to 2.50v on 8/17/23.On (b)(6) 2023 it was confirmed that the device had reset to start up mode, indicating the device was not detecting or delivering therapy.The neurostimulator was replaced on (b)(6) 2023.Following the implant, the patient interrogated the device and synchronized the data.The data did not appear in pdms as expected.Review of the device sessions identified that the device data was received by the pdms system, but the processor was unable interpret the data.It appears that invalid values are being communicated from the neurostimulator, preventing the processing of the information.The device was explanted on (b)(6) 2023 and is being returned for investigation.

Manufacturer Narrative

(b)(4).Neuropace is in process of investigating the explanted product.

Manufacturer Narrative

(b)(4).Investigation results - this failure was caused by a logic defect in the cinco asic.Specifically, this failure is in the st fifo which is part of the telemetry controller.

Event Description

Original report: following the implant, the patient interrogated the device and synchronized the data.The data did not appear in pdms as expected.Review of the device sessions identified that the device data was received by the pdms system, but the processor was unable interpret the data.It appears that invalid values are being communicated from the neurostimulator, preventing the processing of the information.The device was explanted on (b)(6) 2023.

• 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: 17967250
• MDR Text Key: 326072585
• Report Number: 3004426659-2023-00050
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617231207
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS-320-K - FGI
• Device Catalogue Number: 1008191
• Device Lot Number: 33116-1-1-1
• Date Manufacturer Received: 10/25/2023
• 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; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female