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

Model Number RNS-300M-K

Device Problems Device Remains Activated (1525); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Swelling (2091)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant occurred on (b)(6) 2017.The patient was implanted with rns (right occipital region) and two leads (dl-330-3.5, sn (b)(4), port 1, right temporal)(cl-335-10, sn (b)(4), port 2, right parietal).Burr hole cover was used.Implant followed a 14 day invasive monitoring, patient was not previously implanted with vns, no vancomycin powder was used, suture closure.The rns system is currently programmed for detection only.Remains implanted.

Event Description

The site reported that the patient who was implanted on (b)(6) 2017 called the site last week because he couldn't move the left side of his face.He was told to go to the er but he never did.Yesterday he had his 1-month appointment.Charlotte said it looked like he had a stroke, presenting with left side of face droop and left side weakness.He was evaluated at the site and it has yet to be determined if he had a stroke or if there is something else going on.He was admitted yesterday and there was testing of csf for possible infection.Subject reported that dog's paw hit him in head near implant on (b)(6) 2017.He reported left facial droop on (b)(6) 2017 and was told to go to ed but did not.At (b)(6) 2017 visit, subject reported left upper extremity weakness.Pi sent subject for urgent ct/cta.Results show no evidence of hemorrhage.Hypodensity surrounds depth electrode, but etiology unclear - stroke, infection, immune reaction, traumatic disruption of lead? admitted for workup.On (b)(6) 2017, lumbar puncture shows infection unlikely.Start decadron today.Patient has since been released and is doing well.The rns system remains implanted and programmed for detection only.

• 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: 6371874
• MDR Text Key: 68784478
• Report Number: 3004426659-2017-00010
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170518
• 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: 02/28/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/02/2017
• 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: 28 YR