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

Model Number CL-325-10-K

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The implant procedure was discontinued after the patient experienced a serious bleed.Any rns system product implanted was explanted at the time of the event.

Event Description

The patient underwent successful placement of an rns system depth lead during the initial implant procedure.However when attempting to open the dura for placement of a cortical strip lead, the patient experienced significant bleeding.The neurosurgeon abandoned the procedure and explanted the depth lead.A larger craniotomy was created to relieve pressure on the skin.Post-wound closure, the patient was sent for a ct scan.The neurosurgeon suspected a venous infarct, considering the patient has undergone previous cranial surgeries (not related to the rns system) which led to scar tissue and dural adhesions.As of (b)(6) 2021 the patient is reported to be very weak and aphasic.

• 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: 12389049
• MDR Text Key: 268957990
• Report Number: 3004426659-2021-00042
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005311
• UDI-Public: 010085554700531117240127
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CL-325-10-K
• Device Catalogue Number: 1007933
• Device Lot Number: 30852-1-1-1
• Date Manufacturer Received: 07/21/2021
• 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: 46 YR