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

Model Number RNS-300-K

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

Patient Problem Emotional Changes (1831)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).- the rns system leads are placed in the frontal lobe.

Event Description

The treating clinician reported the patient was experiencing behavioral changes, specifically: vulgarity in conversations, irresponsibility, and lack of empathy.The changes in behavior corresponded with programming changes implemented on (b)(6) 2019 and were observed leading up to the (b)(6) clinic visit.Per the treating clinician, reduction of the programmed current resulted in a decrease in the behavioral changes.The physician will continue to titrate the rns neurostimulator settings.The patient is noted to have behavioral issues with his seizures, however the changes noted were not consistent with the patient's medical history.The patient's rns system leads are placed in the frontal lobe.

• 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: 8798425
• MDR Text Key: 151305220
• Report Number: 3004426659-2019-00028
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017181223
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-300-K
• Device Catalogue Number: 1007910
• Device Lot Number: 25858-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• 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): Other
• Patient Age: 54 YR