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 Unspecified Infection (1930)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is the patients fourth rns neurostimulator.

Event Description

Neuropace was informed on (b)(6) 2018 that the patient was diagnosed with a wound infection.On (b)(6) 2017 the patient underwent a routine battery replacement surgery.There were no surgical complications reported.On (b)(6) 2017 the patient went to emergency room (er) due to pain at the incision site.No medications were given by the er and labs were drawn.The patient was seen by neurosurgery on (b)(6) 2017 and was given a short course of antibiotics.The patient had a razor cut near the incision site, likely caused by the patient shaving his head after the neurostimulator replacement.On (b)(6) 2017 the patient went to the er and reported that after having a seizure, he bumped his head.A small area of granulation tissue on the occiput was observed without active drainage although a dried yellow crust was noted.The er physician suspected possible cellulitis and started the patient on an oral antibiotic as well as a topical antibiotic ointment.On (b)(6) 2018, the patient was seen by a neurosurgeon and the decision was made to explant the rns neurostimulator and leads.A picc line was placed and a 6 week course of iv antibiotics started.The patient was discharged from the hospital on (b)(6) 2018.

• 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 ; 6502372788
• MDR Report Key: 7204476
• MDR Text Key: 97712557
• Report Number: 3004426659-2018-00001
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017180104
• 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: 01/15/2018

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-300M-K
• Device Catalogue Number: 1007910
• Device Lot Number: 23889-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/18/2018
• 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: 39 YR