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

Model Number	RNS-320-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Erosion (2075)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns system remains implanted and programmed for use.
Event or Problem Description
On (b)(6) 2021 patient presented to er regarding skin breakdown over the surgical site after rns implant.The patient was hospitalized and started on iv antibiotics cefepime and vanomycin.On (b)(6) 2021 patient underwent a wound washout.The patient was discharged on (b)(6) 2021 with vancomycin and ceftriaxone until (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).The rns system was explanted and not returned for investigation.
Event or Problem Description
Original report : on (b)(6) 2021 patient presented to er regarding skin breakdown over the surgical site after rns implant.The patient was hospitalized and started on iv antibiotics cefepime and vanomycin.On (b)(6) 2021 patient underwent a wound washout.The patient was discharged on (b)(6) 2021 with vancomycin and ceftriaxone until (b)(6) 2021.Updated information: patient had a rns system explanted on (b)(6) 2021.

• 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: 12661347
• Report Number: 3004426659-2021-00051
• Device Sequence Number: 6760425
• 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: 2021
• 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): 08/30/2023

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: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 29547-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 08/30/2023
• 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: Other
• Patient Age: 37 YR
• Patient Sex: Female