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

Model Number CL-325-10-K - FGI, LEADS, CL-325-10-K

Device Problems Under-Sensing (1661); Missing Value Reason (3192)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pending product return for further investigation.The patient is currently implanted with the rns system and is programmed for detection and treatment.The patient was not adversely affected by this event.Pending product return.

Event Description

During the case, there was no real time ecog signal observed on contacts 1 & 2 of the cortical strip lead connected to port 1.Troubleshooting was performed and the lead was moved to other locations on the cortical surface of the brain with no real time ecog signal observed.The lead was then cleaned and placed in port 2 to confirm lead vs neurostimulator issue and with the same result of no signal observed on contacts 1 and 2.Other leads that were implanted were connected and we observed good recording throughout the system.The neurosurgeon removed the cortical strip lead in question and implanted a new cortical strip lead.All contacts on this new lead recorded properly.

Manufacturer Narrative

Comp-(b)(4).No malfunction was observed.Unable to duplicate reported failure.The lead was returned to neuropace for investigation.There were no noticeable deformations or damage to: the lead body, coil, welds, electrode, or contacts.No gaps were observed in the coil.There was some bending of the lead which is most likely a result of the implant process.Continuity testing passed on all four channels.Impedance testing passed all four channels.Observed a 'kink' in the polyimide between the second and third contacts - this did not affect lead electrical performance and is most likely due to manipulation after implant.

Event Description

New information (b)(6) 2016 presented.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 6502382788
• MDR Report Key: 6150953
• MDR Text Key: 61706567
• Report Number: 3004426659-2016-00033
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917181119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CL-325-10-K - FGI, LEADS, CL-325-10-K
• Device Catalogue Number: 1007609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR