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

Model Number RNS-320-K - FGI

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

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - neuropace received the device back on 6/20/23 for investigation.No defects were identified during the production of the device, it has been manufactured and released per our specifications.Investigation of the device sessions identified that the byte at 0x37 is bad in scratch pad memory.The investigation of the returned rns neurostimulator is in process.

Event Description

During programming of the rns neurostimulator, the rns would not retain the lead labels, preventing programming of the rns.Detection was enabled at implant (b)(6) 2023.Detection disabled on (b)(6) 2023.The rns neurostimulator was replaced on (b)(6) 2023.The rns neurostimulator was returned to neuropace for investigation.

Event Description

Original report - during programming of the rns neurostimulator, the rns would not retain the lead labels, preventing programming of the rns neurostimulator.Detection was enabled at implant (b)(6) 2023).Detection disabled on (b)(6) 2023.The rns neurostimulator was replaced on (b)(6) 2023.New information -investigation of the returned device was completed.Refer to section h10.

Manufacturer Narrative

(b)(4) investigation of the returned neurostimulator confirmed a logic defect in the cinco asic.A corrective action has been created to address this issue.

• 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
• MDR Report Key: 17292465
• MDR Text Key: 318960934
• Report Number: 3004426659-2023-00030
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617230913
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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: 33075-1-1-1
• 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): Hospitalization; Other
• Patient Age: 11 YR
• Patient Sex: Male