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

Model Number RNS 320

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

Patient Problems Foreign Body Reaction (1868); Neuropathy (1983); Swelling/ Edema (4577)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted neurostimulator and leads were not returned for investigation.

Event Description

The patient was initially implanted on (b)(6) 2020 with the neurostimulator in the left parietal lobe, and two depth leads in the left parietal and temporal lobes.On (b)(6) 2022, the patient developed lethargy, dysarthria, and worsening of baseline right sided weakness for approximately 2 weeks prior to presentation.When family members alerted the medical team to these changes they were advised to come to the emergency room for urgent evaluation.Reported as edema and cyst formation around leads.Treatment included - hospitalization, left parietal craniectomy for rns explant, fluid collection, and mesh cranioplasty.Seven days of iv antibiotics were given, however cultures remained negative, the patient afebrile and with reassuring bloodwork.A follow up mri on post op day 6 was more consistent with an immune response vs demyelination / multiple sclerosis flare.

• 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: 13501648
• MDR Text Key: 285702825
• Report Number: 3004426659-2022-00003
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617220714
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS 320
• Device Catalogue Number: 1007927
• Device Lot Number: 31869-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• 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; Required Intervention; Hospitalization
• Patient Age: 20 YR
• Patient Sex: Female