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 Intracranial Hemorrhage (1891); Muscle Weakness (1967); Cerebral Edema (4403)

Event Date 03/23/2022

Event Type  Injury  

Event Description

The patient woke up with right hand weakness that progressed to her shoulder, and slight leg weakness.After six hours the patient went to er with worsened right arm weakness.Imaging was done and the patient was diagnosed with a hemorrhage.Ct, mri, conventional angiogram did not reveal any vascular abnormality.The report revealed a focal round area of high attenuation measuring 2x2x1.5 cm (high left frontal parietal adjacent to the neurostimulator).Negative cta.No seizure or head trauma was reported, which could have contributed to the event.Residual sequelae includes right hemiparesis with no movement of right arm.The patient reportedly will undergo physical therapy.

Manufacturer Narrative

(b)(4) - the rns system is contraindicated for use with patients at high risk for surgical complications such as active systemic infection, coagulation disorders (such as antithrombotic therapies) or platelet counts below 50, 000.The rns neurostimulator and leads remain implanted and programmed for use.

• 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
• MDR Report Key: 16649963
• MDR Text Key: 312409150
• Report Number: 3004426659-2023-00011
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210827
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30524-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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): Other
• Patient Age: 16 YR
• Patient Sex: Female