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

Model Number	RNS 320
Medical Device Problem Codes	Failure to Interrogate (1332); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results - investigation in process.Neuropace confirmed a significant dent on the explanted neurostimulator can.
Event or Problem Description
The patient reported that he was unable to interrogate his device after experiencing a fall.The neurostimulator was replaced on (b)(6) 2023.A significant dent was noted on the top can of the neurostimulator when it was explanted.The neurostimulator was returned for investigation.
Additional Manufacturer Narrative
(b)(4).Investigation results: testing confirmed an intermittent connection in the pca circuit.This pca was subjected to a severe impact transmitted from the device can through the internal frame.Most probably the impact to the pca cracked some number of solder ball connections between the sdbga and the pca or possibly traces in the pcb itself were compromised.The intermittent electrical performance of this pca is consistent with the existence of intermittent circuit connections.
Event or Problem Description
Original report - the patient reported that he was unable to interrogate his device after experiencing a fall.The neurostimulator was replaced on 1/16/23.A significant dent was noted on the top can of the neurostimulator when it was explanted.The neurostimulator was returned for investigation.Investigation results: testing confirmed an intermittent connection in the pca circuit.This pca was subjected to a severe impact transmitted from the device can through the internal frame.Most probably the impact to the pca cracked some number of solder ball connections between the sdbga and the pca or possibly traces in the pcb itself were compromised.The intermittent electrical performance of this pca is consistent with the existence of intermittent circuit connections.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: 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: 16374661
• Report Number: 3004426659-2023-00003
• Device Sequence Number: 15142955
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717201018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 29547-1-1-1
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 43 YR
• Patient Sex: Male