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

Model Number DL-330-10-K

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

Patient Problems Hematoma (1884); Muscle Weakness (1967)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022, the patient was taken to or for planned stereo-eeg electrode removal and placement of rns with active electrodes over the right lingual gyrus and right lateral occipital region.Inactive electrodes were placed in the right pulvinar nucleus of the thalamus and right mesial temporal area.A follow up ct was performed on (b)(6) 2022 and showed a 4x3 cm right frontal hemorrhage with minimal midline shift.The patient reported no acute complaints.Minimal weakness was observed in the left arm, and there was a left facial droop on physical exam.The patient was monitored clinically and had physical therapy.The symptoms improved and slowly resolved as the hematoma decreased in size.The patient was diagnosed with an intraparenchymal hematoma.

• 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: 16491723
• MDR Text Key: 310774926
• Report Number: 3004426659-2023-00009
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005335
• UDI-Public: 010085554700533517250608
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007929
• Device Lot Number: 32572-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2023
• 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
• Patient Age: 12 YR
• Patient Sex: Male