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

Model Number	DL-330-3.5-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The left thalamus (cm) depth lead was replaced on (b)(6) 2024 after artifact and high impedance were observed during an ecog review in (b)(6)2023.A programming change was made at that time; the contacts involved with the high impedances were turned off.The patient was scheduled for a neurostimulator replacement to address routine end of life in (b)(6) 2024 and the lead replacement was performed at this same time.The cause of the break was possibly related to the clip that was used to secure the lead.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
On 09 dec 2024 the left thalamus (cm) depth lead was replaced following artifact and high impedance which was observed during an ecog review earlier in the year, feb 2024.The first evidence of a lead break was in jan 2024.Troubleshooting included skin palpations while monitoring live ecogs, and initial treatment was to modify programming of the lead.The cause of the lead break was not determined.
Additional Manufacturer Narrative
Comp-(b)(4).The explanted product was not returned to neuropace for analysis.Correction to - the origianlly submitted report was 3004426659-00082.2024-00082 has been resubmitted and this follow up is the ture.

• 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: 21023393
• Report Number: 3004426659-2024-00081
• Device Sequence Number: 8330078
• Product Code: PFN
• UDI-Device Identifier: 00855547005342
• UDI-Public: 010085554700534217251207
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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-330-3.5-K
• Device Catalogue Number: 1007928
• Device Lot Number: 32967-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 12 YR
• Patient Sex: Female