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

Model Number	RNS-300M-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The patient was initially implanted with the neurostimulator and three depth leads.
Event or Problem Description
The patient was admitted to the hospital on (b)(6) 2018 for red, painful scalp and fever.He was seen by an infectious disease specialist and prescribed antibiotics for scalp cellulitis.The patient was discharged on (b)(6) 2018.On (b)(6) 2018 the patient was seen by his neurologist and another week of antibiotics was prescribed.The patient was seen again on (b)(6) 2018, at which time it was determined that the system would be explanted on (b)(6) 2018.Neuropace received the explanted rns system (neurostimulator and leads).There was no evidence of factors that could have caused or contributed to the reported event.No evidence of product malfunction or failure.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; montian view CA 94043
• MDR Report Key: 7446764
• Report Number: 3004426659-2018-00012
• Device Sequence Number: 1769142
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017180430
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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
• Operator of Device: Physician
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007910
• Device Lot Number: 24506-1-1-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR