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

Model Number RNS-300M-K

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

Patient Problem Erosion (1750)

Event Date 02/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is the patient's third neurostimulator implanted on (b)(6) 2016.Patient is implanted with a cortical strip lead (port 1, sn (b)(4)) and depth lead (port 2, sn (b)(4)).Continued use.

Event Description

The patient called the neuropace representative stating that he scratched his head resulting in the scab coming off and the hardware is now visible.The fce instructed him to go to the (b)(6) er for treatment.Details from the study site coordinator - the patient called the site coordinator to report that on the morning of (b)(6) 2017 he woke up with a hole in his head and brain fluid all over.He called the number on his neuropace wallet card and was referred to the medical university of (b)(6).The patient did not see any blood coming from the open area.The patient was evaluated by the neurosurgery team who observed yellow clear fluid that appears to be csf leaking from open wound on top of scalp; wires (leads) were visible in a picture taken by the patient.The patient was admitted for washout, closure, and skin repair with long-term suppressive antibiotics.Skull skin flap elevated and intracranial electrodes were mobilized from the erosion.Active problems at discharge: infection of brain stimulator.Exposure of implanted material to surrounding tissue.Ct head - small bilateral meningoceles seen along previously resected zygomatic segments of temporal bone.Treated with three days of iv vancomycin.Discharged on oral bactrim but after culture changed to penicillin vk 1000 mg three times daily for 10 days on (b)(6) 2017.On (b)(6) 2017 it was decided to readmit subject for placement of picc line and longer term course of iv antibiotics.The rns system remains implanted.The rns system is currently programmed for detection and treatment.

• 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: 6417300
• MDR Text Key: 70339803
• Report Number: 3004426659-2017-00012
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017160526
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Device Unattended
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2017
• 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: 38 YR