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

Model Number DL-330-3.5-K

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

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Sleep Dysfunction (2517); Speech Disorder (4415)

Event Date 04/04/2022

Event Type  Injury  

Event Description

The patient was implanted with bilateral centromedian thalamic leads on (b)(6) 2022.The patient presented with symptoms (headache, somnolence, and aphasia) 10 days post-op.The mother reported that the patient has limited speech; previously he spoke in sentences.Initial information provided is that post-op ct was unremarkable.No neurosurgical intervention at this time.Diagnosed as a right frontal intraparenchymal hemorrhage.This patient had an mri on thursday, (b)(6) 2022.It showed the bleeding had stopped.The patient is stable.The patient remains hospitalized; he is pending rehabilitation admittance.

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.The device is currently programmed for detection only.

• 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: 14397394
• MDR Text Key: 294676816
• Report Number: 3004426659-2022-00009
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005038
• UDI-Public: 010085554700503817221118
• 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 Assistant
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DL-330-3.5-K
• Device Catalogue Number: 1007604
• Device Lot Number: 29370-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• 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; Other
• Patient Age: 16 YR
• Patient Sex: Male