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

Model Number	RNS-320-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Unspecified Infection (1930); Twiddlers Syndrome (4563)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
The patient presented to neurosurgery with scalp pain earlier in june.Upon inspection, there was scalp erosion and infection of the area, with a lead extruding from scalp.The patient underwent an rns system explant (neurostimulator and four leads).Additional details were not provided.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
Original report: the patient presented to neurosurgery with scalp pain earlier in june.Upon inspection, there was scalp erosion and infection of the area, with a lead extruding from scalp.The patient underwent an rns system explant (neurostimulator and four leads).Updated information: on (b)(6) 2024, the patient reported drainage from the top of her head while washing her hair.Examination revealed an area of excoriation.The patient was given a course of antibiotics.She was re-evaluated a week later, and the drainage had resolved, however a lead was exposed, having eroded through the skin.6/20/24 she was taken to the or for exploration, and once her hair was clipped, she was found to have at least three areas of lead exposure due to erosion through the scalp, and an area of erosion over the posterior corner of the generator.The decision was made at that time to remove the entire system, as there had been multiple areas of lead and generator exposure for an unknown period of time.Cultures taken during clinic were positive for s.Aureus.Antibiotic treatment included oral and iv.Keflex (1 week), oxacillin (4 weeks).Diagnosed as a deep incisional infection with areas of scalp erosion with exposure of leads and generator (erosion).

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: 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 ; 5108822607
• MDR Report Key: 19751818
• Report Number: 3004426659-2024-00054
• Device Sequence Number: 20466048
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 26754-1-1-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 26 YR
• Patient Sex: Female