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

Model Number RNS-300M-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient was implanted on (b)(6) 2017 immediately following invasive monitoring.Patient was implanted with two leads: cortical strip lead (model cl-325-10) placed in the left frontal motor cortex connected to port 1.Depth lead (model dl-330-3.5) placed in the left hippocampus connected to port 2.In addition to implant with the rns system, the patient underwent a concurrent frontal resection.

Event Description

Patient reported to the surgeon that she felt leaking from her wound starting approximately the week of (b)(6) 2017, 10 weeks after invasive monitoring which was immediately followed by rns system implant and concurrent resection.No other symptoms were reported.Treatment included surgical intervention to close the wound and lumbar drain to address the csf leak.No cultures were taken; the surgeon did not believe there was an infection but planned to treat the patient prophylactically with antibiotics.

• 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: 6868523
• MDR Text Key: 86302788
• Report Number: 3004426659-2017-00039
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005137
• UDI-Public: 0100855547005137
• 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
• Report Date: 09/15/2017

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
• Device Operator: Physician
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 23602-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 26 YR