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

Model Number	CL-325-10-K
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The rns system remains implanted and programmed for use.
Event or Problem Description
The patient has a pre-implant history of non-epileptic events with bilateral sensory phenomena with no electrographic correlate seen on recorded ecogs after implant with the rns system.The symptoms progressed post-implant from bilateral sensory symptoms to distal left hand weakness which spread to involve the entire arm.Due to the progression of the symptoms, the patient presented at the emergency department where a head ct was performed that identified an intraparenchymal hemorrhage located adjacent to the unconnected strip lead.Multiple mris were performed 11/1/2020- 11/4/2020 which indicated a change in location of the unconnected strip lead since initial implant.On 11/05/2020 the patient was taken to the or for surgical evacuation of the hemorrhage and removal of the unconnected strip lead.

• 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: 10953128
• Report Number: 3004426659-2020-00060
• Device Sequence Number: 19641011
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917210109
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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: No Information
• Device Model Number: CL-325-10-K
• Device Catalogue Number: 1007609
• Device Lot Number: 25264-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/05/2020
• 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: 17 YR