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

Model Number RNS-320-K

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Temporary discomfort from stimulation is an identified risk of the rns system.The rns system patient manual states: "the neurostimulator delivers electrical stimulation to the brain when it detects brain activity that your doctor feels could show the start of a seizure.You should not feel the stimulation but it is possible that you might feel a brief tingling sensation in your scalp or pain in your head.If you do, talk to your doctor so that changes can be made to the neurostimulator settings.".

Event Description

The patient reported feeling an "electrical shock" midway through interrogating the rns neurostimulator with the remote monitor.The shock-like sensation occurred each time the patient uses the remote monitor and started after the recent rns neurostimulator replacement in (b)(6) 2019.The treating center attempted to replicate the scenario using the rns® tablet and stimulation testing.During interrogation of the rns neurostimulator with the tablet, the patient reported feeling the sensation.Changes were made to the neurostimulator stimulation settings and the patient will follow-up with the treating center to report if the sensation is resolved.No further information has been provided by the treating center.

• 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: 8937344
• MDR Text Key: 159518716
• Report Number: 3004426659-2019-00038
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200228
• 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: 08/27/2019

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: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 27654-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/27/2019
• 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: 40 YR