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

Model Number	DL-344-3.5-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).On (b)(6) 2016 patient was implanted with the rns system including two depth leads (sn (b)(4)left mesial temporal and (b)(4) right mesial temporal).Both leads were secured with dog bones.This record is associated with 3004426659-2017-00003.Product damaged during explant.
Event or Problem Description
On (b)(6) 2016 the patient ecogs were reviewed and square signals were observed on channels 1 and 2 (sn (b)(4)) additional testing of the lead impedances revealed insufficient charge and irregularity in the lead signal.Based on troubleshooting it was believed that the irregular signal was a result of a lead break.There was no indication of signal issue with the right lead at that time.The left lead detection and therapy were disabled.On (b)(6) 2016 the patient returned for follow up.It was noted that the left depth lead issues continued and impedances/ecog signals were abnormal.It was brought to dr.(b)(6) attention that on (b)(6) 2016 there was artifact seen on the right depth lead (sn (b)(4)) as well and impedance checks revealed that there was 'insufficient charge' on contact rhip4.Dr.(b)(6) counseled the patient on replacing both leads as she felt the troubleshooting indicated both leads were possibly fractured.On (b)(6) 2016- during the surgical case, after exposing the device, the left and right depth leads were removed from their original ports and placed in the opposite ports.(left depth=port2 / right depth=port1) impedances and ecog signals were then checked and it was verified that the abnormal impedances and artifactual signals followed the lead swap.This confirmed the issue was with the leads and not the ipg itself.Both leads were then explanted and sent to pathology.New leads were implanted and all impedances were wnl (within normal limits).Ecog signals were appropriate per dr.(b)(6).Leads will not be returned for investigation they were both stretched/damaged during the explant process.

• 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: 6279244
• Report Number: 3004426659-2017-00005
• Device Sequence Number: 1248671
• Product Code: PFN
• UDI-Device Identifier: 00855547005021
• UDI-Public: 010085554700502117180210
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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-344-3.5-K
• Device Catalogue Number: 1007606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 01/26/2017
• 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: 49 YR