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 Purulent Discharge (1812); Headache (1880); Pain (1994); Drug Resistant Bacterial Infection (4553)

Event Date 02/08/2024

Event Type  Injury  

Event Description

The patient's onset date was reported as (b)(6) 2024 with purulent drainage from his superior incision.The patient reported possible head trauma 1 week prior, possibly from a nighttime seizure and waking up with a scalp laceration.The patient experienced pain when combing hair and then purulent discharge was observed two days prior to presenting to the emergency department.The patient also reported a headache, but no fever.There was frank purulent material above the rns battery and synthetic flap.There was purulent material beneath the flap.On (b)(6) 2024 the patient was initially given one dose of ceftriaxone and then underwent a right sided wound washout and revision, right sided craniectomy of prior synthetic implant and right sided removal of rns electrodes and neurostimulator.Treatment included ceftriaxone one dose prior to or, then continued on ceftriaxone and vancomycin.

Manufacturer Narrative

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

• 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 ; 5108822607
• MDR Report Key: 18759878
• MDR Text Key: 336012145
• Report Number: 3004426659-2024-00016
• Device Sequence Number: 1
• Product Code: PFN
• 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: 02/15/2024

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: 1008191
• Device Lot Number: 32376-1-1-1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Male