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

Model Number	DL-344-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lead remains implanted but disconnected from the neurostimulator.
Event or Problem Description
In jan 2021 the patient was implanted with the rns neurostimulator and three leads (two depth leads in the right hemisphere and one strip lead in the left hemisphere.One depth lead and one strip lead were connected to the rns neurostimulator during the procedure).In jun 2022 there was unusual signal observed on the right depth lead during ecog review.At that time the doctor felt that there was sufficient lead activity and no changes were made.In july 2022, the signal artifact was determined to be on the third contact of the right depth lead.During the jul 2022 clinical visit the lead in question was programmed to discontinue stimulation but detection was left active.The patient does experience fall seizures, which may be the cause of the lead break.On (b)(6) 2022 the patient underwent a lead revision.The lead in question was disconnected from the neurostimulator and the other (previously implanted) depth lead was connected.The lead in question remains implanted.

• 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 ; 6502382788
• MDR Report Key: 15934169
• Report Number: 3004426659-2022-00050
• Device Sequence Number: 19929548
• Product Code: PFN
• UDI-Device Identifier: 00855547005298
• UDI-Public: 010085554700529817230929
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: DL-344-10-K
• Device Catalogue Number: 1007931
• Device Lot Number: 30378-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 42 YR
• Patient Sex: Male