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 Problems Visual Impairment (2138); Visual Disturbances (2140)

Event Date 07/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Rns device implanted on right parietal section of the skull.Two leads: port1, cl-325-10, sn (b)(4), right inferior occipital.Port2, cl-325-10, sn (b)(4), right superior occipital.

Event Description

Neuropace was informed in june 2017 that the patient had reported a blind spot in her visual field.The patient was worked up for visual field testing and the treating physician felt that the visual field changes were not attributable to the rns system; therefore the event was not reported.No changes to responsive stimulation were made at that time.In (b)(6) 2017, the patient was seen by a different physician and at that time responsive stimulation was disabled in order to determine the effectiveness of the rns system on the patient's seizures.While responsive stimulation was disabled, the patient continued to have visual field changes and was subsequently hospitalized.During hospitalization, further diagnostic testing was performed.Responsive stimulation was re-enabled in august and the physician stated that the visual field changes could be attributed to the rns system implant.

• 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: 6858130
• MDR Text Key: 85782271
• Report Number: 3004426659-2017-00041
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151103
• 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: 09/11/2017

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: 20127-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/12/2017
• 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: 24 YR