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

Model Number	DL-344-10-K
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted lead was not returned to neuropace for analysis, however review of the lead impedance and ecog data was performed and the data is consistent with a lead break.
Event or Problem Description
In (b)(6) 2017, high impedance was noted on the port 1 left depth lead, indicating a possible lead break.Stimulation and detection were disabled on the lead by the neurosurgeon.The change was not anticipated to affect patient treatment since most events were noted to occur on the contralateral lead.In (b)(6) 2018, the lead was replaced.The lead was not returned to neuropace by the treating center so no additional investigation could be performed.

• 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: 7645804
• Report Number: 3004426659-2018-00020
• Device Sequence Number: 16557174
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417190720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: Physician
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 22420-1-1-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/28/2018
• 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