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 Bacterial Infection (1735); Erosion (1750); Fluid Discharge (2686)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

Event Description

The patient reported that she had gone to the emergency room (er) (date not provided) during this visit, labs and a ct were ordered.All results were normal.On (b)(6) 2022, the patient contacted the app twice and sent pictures of the patients scalp showing the exposed neurostimulator.On (b)(6) 2022, the patient underwent an explant of the rns neurostimulator and two depth leads.The patient was diagnosed with an epidural infection.

• 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: 15695938
• MDR Text Key: 302683742
• Report Number: 3004426659-2022-00042
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200220
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320
• Device Catalogue Number: 1007694
• Device Lot Number: 27572-1-1-1
• Date Manufacturer Received: 10/05/2022
• 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): Disability; Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female