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 12/11/2023

Event Type  malfunction  

Event Description

The patient underwent an mri on (b)(6) 2023, the rns was placed in mri enabled mode prior to the mri.The treating clinician attempted to place the device back to normal operating mode, but was unable to communicate with the device.Troubleshooting was performed along with support from neuropace field clinical engineering but it was determined that the device was no longer functional and needed to be replaced.The device was replaced without complication on (b)(6) 2023.

Manufacturer Narrative

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

Event Description

Original report: the patient underwent an mri on (b)(6) 2023, the rns was placed in mri enabled mode prior to the mri.The treating clinician attempted to place the device back to normal operating mode, but was unable to communicate with the device.Troubleshooting was performed along with support from neuropace field clinical engineering but it was determined that the device was no longer functional and needed to be replaced.The device was replaced without complication on (b)(6) 2023.

Manufacturer Narrative

(b)(4).This device failed due to exposure to an mri procedure.Such a procedure is known to expose the device to strong fields that induce a voltage on the patient leads.The cinco 1e asic internal power supplies can be susceptible to failure under these conditions.Though there is no evidence of physical damage to the device this failed state is unrecoverable without gaining physical access to the circuit.

• 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: 18490086
• MDR Text Key: 332998676
• Report Number: 3004426659-2023-00068
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617211120
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS 320
• Device Catalogue Number: 1007927
• Device Lot Number: 30925-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• 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: 29 YR
• Patient Sex: Female