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

Model Number	DL-330-10-K
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Codes	Head Injury (1879); Injury (2348)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
During a routine rns neurostimulator replacement, the surgeon noted that it appeared as if the outer insulation layer was coming off a small region of the lead body, a few centimeters away from the neurostimulator on the lead connected to port 1.The surgeon stated the insulation had penetrated into the patient's scalp and caused a small wound.The lead demonstrated normal signals and impedance measurements upon connection and testing with the new neurostimulator.For this reason the lead was not explanted.Prior to closing the scalp incision, the surgical site was irrigated with pulsed lavage, and a patch of dura regeneration matrix was placed between the scalp and the region of the lead body where the insulation layer was coming off.No additional information nor were any pictures of the area of the lead in question were 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.; mountain view CA 94043
• MDR Report Key: 8201779
• Report Number: 3004426659-2018-00050
• Device Sequence Number: 1448607
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517180310
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 20016-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/27/2018
• 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: Required Intervention
• Patient Age: 22 YR