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

Model Number	CL-325-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Partial Hearing Loss (4472); Swelling/ Edema (4577)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
The patient started to notice a boggy area of fluid on her scalp and then experienced some hearing loss.Details are unclear, because the patient was seen at yale at this time.Ultimately, a ct was completed.The ct showed a pseudomeningocele.At yale, the patient underwent repair of the dura and drainage of the pseudomeningocele with lumbar drain placement.The patient noticed the same boggy area and hearing loss in the spring of 2024.A head ct was completed.The ct showed a pseudomeningocele around the same lead.The patient underwent removal of left temporal strip leads x 3.New left pulvinar and left hippocampal leads were placed.According to the pa, the rns strip lead eroded at the dura, the chronic dural opening caused a pseudomeningocele to form.The fluid drained toward the ear and caused a sensorineural hearing loss due to the fluid building up in the inner ear.The hearing loss has resolved now that the fluid has been drained.The patient is back to her baseline and doing well.

• 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: 20066670
• Report Number: 3004426659-2024-00065
• Device Sequence Number: 7839898
• Product Code: PFN
• UDI-Device Identifier: 00855547005311
• UDI-Public: 010085554700531117240311
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CL-325-10
• Device Catalogue Number: 1007933
• Device Lot Number: 31012-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/26/2024
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female