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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Fluid Discharge (2686); Test Result (2695)

Event Date 06/23/2015

Event Type  Injury  

Event Description

On (b)(6) 2014: patient was implanted after phase ii testing with rns neurostimulator, one depth lead ((b)(4)) and three cortical strip leads ((b)(4)).The depth lead was placed in the left hippocampus; the strip lead that was connected to the neurostimulator was placed in the left temporal region.The remaining two leads were not connected and were placed as follows: left sub-temporal and left temporal mid-lateral.On (b)(6) 2015: patient was scheduled for a left temporal resection with revision of neuropace implanted depth and strip leads.Neurosurgeon performed a craniotomy for resection and noted a copious amount of discharge under the bone flap extending to the subdural space.Neurosurgeon abandoned the resection and proceeded with explant of all neuropace implanted product.Neurosurgeon noted that further laboratory analysis would be needed to identify discharge.Pre-surgical workup for patient indicated no evidence or clinical signs of infection.On (b)(6) 2015: workup summary and patient update received from the nurse practitioner at (b)(6).Operating room lab cultures were taken at the latest surgery on (b)(6) 2015.The cultures grew out p.Acnes on the culture broth.Other plates were negative as of (b)(6) 2015.Esr=1 (esr is used as a marker for tissue inflammation).Normal is 0-20 for women.C-reactive protein was less than 5 (another type of marker for tissue inflammation.) the patient was started on ceftriaxone after surgery along with vancomycin.The vancomycin was discontinued after the results came back from the lab.Patient is being maintained on ceftriaxone 2gm x 6 weeks total.This antibiotic will be given by iv thru a pic line.

Manufacturer Narrative

(b)(4).No product return.

• 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: 4928923
• MDR Text Key: 6431093
• Report Number: 3004426659-2015-00005
• 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
• Type of Report: Initial
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• 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: 27 YR