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

Model Number RNS 320

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

The patient had her device placed in mri mode and then underwent an mri.Following the mri, the neurostimulator would not communicate with a programmer nor the remote monitor on (b)(6) 2023 the neurostimulator was replaced and returned to neuropace for investigation.

Manufacturer Narrative

(b)(4).The explanted device was returned to neuropace and is undergoing analysis.

Manufacturer Narrative

(b)(4) investigation this device experienced an externally impressed voltage during an mri procedure.The cinco 1e asic in this device went to a non-functional state wherein the internal regulated power supplies are stable at nearly zero volts.Cycling the power returned the device to normal operation.This is a known behavior of the cinco 1e asic.

Event Description

Original report- the patient had her device placed in mri mode and then underwent an mri.Following the mri, the neurostimulator would not communicate with a programmer nor the remote monitor.On (b)(6) 2023 the neurostimulator was replaced and returned to neuropace for investigation.

• 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: 18183483
• MDR Text Key: 328688945
• Report Number: 3004426659-2023-00058
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190105
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS 320
• Device Catalogue Number: 1007694
• Device Lot Number: 25349-1-1-1
• Date Manufacturer Received: 01/02/2024
• 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): Hospitalization; Other
• Patient Age: 26 YR
• Patient Sex: Female