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

Model Number 1007603

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

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 07/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

(b)(6) 2016 patient was implanted with the rns system including the rns neurostimulator (sn (b)(4)) and two cortical strip leads ( sn (b)(4)).The leads were placed in the right frontal parietal region of the brain.(b)(6) 2016 the patient presented with symptoms.(b)(6) 2016 patient had a system explant due to a brain abscess.Abscess was located in the epidural and subdural space.The patient was treated with iv antibiotics followed by oral antibiotics.The rns system was programmed for detection but not treatment.Last ecog was synchronized on (b)(6) 2016.The rns system was discarded.The abscess occurred approximately three months after implant.Medical affairs manager, (b)(4) spoke with (b)(6), md regarding adverse event.Dr.(b)(6) stated that the patient had a tumor resected years before and developed an osteomyelitis resulting in placement of a cranioplast plate.This may have put the patient in a higher risk category for recurrent infection.Dr.(b)(6) stated that the patient presented with a (1) cm boggy area under a portion of the incision line.There was minimal drainage at the site.When the patient underwent surgical exploration of the area, there was copious amounts of pus above and under the cranioplast plate along with pus both in the epidural and subdural space.Patient did undergo phase 2 monitoring which lasted 7 days prior to implant of the rns system.

• 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: 5855305
• MDR Text Key: 51443667
• Report Number: 3004426659-2016-00019
• 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: Physician
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• 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: 46 YR