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

Model Number	DL-330-10-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial implant includes rns neurostimulator and 4 leads: two depth leads placed bilaterally in the hippocampus and two cortical strip leads placed bi-laterally in the sub-temporal region.
Event or Problem Description
On (b)(6) 2018 the patient was seen for severe right-sided headache, nausea and vomiting, and photosensitivity, all associated with increased frequency of right temporal onset seizures.Ct scan revealed that the patient had an intraparenchymal subdural hemorrhage in the right temporal lobe located near the right depth lead.The patient was admitted to the icu for monitoring, aeds were adjusted, and serial head cts were performed to monitor bleeding stability.Stimulation over the right hippocampal electrode was disabled.The patient had no residual neurological sequelae.The patient was discharged.No additional details have been provided by the treating center.

• 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: 7372119
• Report Number: 3004426659-2018-00010
• Device Sequence Number: 84441
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017161109
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 21150-1-1-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/26/2018
• 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
• Patient Age: 32 YR