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 Intracranial Hemorrhage (1891); Paresis (1998)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) the rns system remains implanted and programmed for use.

Event Description

The patient underwent implantation with the rns system on (b)(6) 2021.Immediately post-implant, the patient was not able to move his contralateral side.Symptoms started as distal left hand weakness that progressed to involve the left arm and leg.A postop ct was performed and indicated a hemorrhage near the location of the leads (approximately 1cm away), located in the motor cortex.The surgeon hypothesized that the bleed may have been due a vessel which ruptured from the pressure of the implanted leads after surgical closure.No surgical intervention was necessary and by the evening after surgery, the patient demonstrated improvement in arm movement.Multiple post-op cts were taken and no changes were seen in the size/location of the bleed.The patient was subsequently discharged from the hospital.

• 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: 11346626
• MDR Text Key: 232520829
• Report Number: 3004426659-2021-00004
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917220822
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 1007609
• Device Lot Number: 28804-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• 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): Hospitalization
• Patient Age: 26 YR