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

Model Number	1007609
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	02/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The implanted rns system consists of the following rns-300, sn (b)(4); cl-325-10k, sn (b)(4).Device remains implanted.
Event or Problem Description
The patient reported clusters seizures (more intense auras) and severe headache and was admitted into the emu on (b)(6) 2016.A ct scan was performed and the site observed an acute intraparenchymal hemorrhage in the right parietal lobe immediately superior to the most superior strip and adjacent to the prior craniotomy.An angiogram was performed that confirmed an arteriovenous (av) fistula on (b)(6) 2016 and she was taken back for a follow up angiogram on (b)(6) 2016 which no longer revealed the presence of the av fistula.The opinion of the surgeons was that the av fistula thrombosed on its own.The doctor is not taking any action at this time and follow up ct scan is planned for two weeks from now.The leads were implanted after phase ii intracranial monitoring ((b)(6) 2015) and the neurostimulator was implanted a month later ((b)(6) 2015) the rns system remains implanted and programmed for detection and treatment.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 5502864
• Report Number: 3004426659-2016-00007
• Device Sequence Number: 18914844
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917180316
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2016

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: 1007609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2016
• Initial Report FDA Received Date: 03/15/2016
• 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: 23 YR