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 Problems Bacterial Infection (1735); Erosion (1750)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This was the patient's third rns device.The original implant was in 2011 with subsequent neurostimulator replacement in 2015.In early 2016 the rns system was explanted and the patient underwent seeg to further localize the seizure network.A new rns system implant (device and leads) occurred on (b)(6) 2016.Explant included the rns device and three depth leads.Device not returned.

Event Description

The patient called the (b)(6) on (b)(6) 2017 and indicated that there was some drainage at the incision location.The patient stated that he first noticed some change approximately one month prior when some scabbing was noticed.On (b)(6) 2017 the patient was subsequently examined and dehiscence was observed at the inferior portion of the left incision (over the device) above the ear.On (b)(6) 2017 the patient presented to the operating room and the incision was opened in the area of dehiscence.No obvious purulence was observed, but the surgical note stated that there was reactive tissue extending from the incision line to the generator.The event occurred > 90 days after implant, categorized as a deep incisional infection.The patient does have drop seizures, but it is unknown whether a fall was causal.

• 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: 6309795
• MDR Text Key: 66763078
• Report Number: 3004426659-2017-00004
• 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: 02/07/2017

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: Physician
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/07/2017
• 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: 35 YR