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 Fever (1858); Convulsion/Seizure (4406); Speech Disorder (4415)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient underwent initial rns system placement with concurrent left temporal lobectomy on (b)(6) 2020.The patient's hospitalization was extended due to post-operative aphasia and seizures.On (b)(6) 2020, the patient developed a high fever with up trending of wbc.A lumbar puncture was performed which indicated pleocytosis, pmn predominant, and all other infectious workups were negative.The treating center identified this as a suspected device-associated cns meningitis.Treatment include iv antibiotics and the patient was discharged to a rehabilitation facility on (b)(6) 2020.The patient was readmitted on (b)(6) 2020 for seizures due non-compliance with medications and medication interactions.A head ct indicated persistent extra-axial fluid collection.On (b)(6) 2020, the patient was taken to the or for drainage of the subdural hygroma and underwent continued antibiotic administration.Culture grew coagulase negative staph.

• 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: 11468028
• MDR Text Key: 241748333
• Report Number: 3004426659-2021-00015
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210730
• 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,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30248-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• 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): Other
• Patient Age: 56 YR