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

Model Number RNS-300-K

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

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns system remains implanted.

Event Description

On (b)(6) 2019 the patient was diagnosed by infectious disease as having a mild bacterial infection at the incision site.The patient was administered antibiotics.Per report, the patient has had an infection since the initial rns system implant, with antibiotics administered since that time and the infection resolving for periods of time but continuing to re-occur.In (b)(6) 2019 the treating center indicated an explant procedure would be scheduled to treat the infection.Additional details were not provided by the treating center.

• 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: 9554751
• MDR Text Key: 175013689
• Report Number: 3004426659-2020-00001
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2020

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 Operator: No Information
• Device Model Number: RNS-300-K
• Device Catalogue Number: 1007603
• Device Lot Number: 23771-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 01/06/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 29 YR