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 Headache (1880); Hematoma (1884)

Event Date 04/09/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.

Event Description

The patient had an open resection of the left anterior medial temporal lobe region on (b)(6) 2023 with revision of the prior placed bilateral hippocampal rns (unchanged on right, electrode moved to posterior margin of resection on the left).Rns device functioned normally after surgery.On (b)(6)/2023, after presenting with progressive headache, ct revealed a large left hemisphere subdural hematoma (sdh), the patient underwent reopening of the left hemisphere craniotomy to evacuate the hematoma.The sdh extended over much of the left hemisphere, including up to the anterior margin of the rns device location.Patient has been doing fine since the evacuation of hematoma procedure, no seizures, no symptoms.

• 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 ; 5108822607
• MDR Report Key: 17121230
• MDR Text Key: 317111148
• Report Number: 3004426659-2023-00027
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200424
• 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: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 28164-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• 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; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female