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 03/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient initially implanted on (b)(6) 2017.Patient was implants with the rns system including the device and three leads.Two depth leads (dl-344 (sn (b)(4), port 1, left mesial temporal), dl-344, (sn (b)(4), port 2, right mesial temporal), cl-325 (sn (b)(4), not connected, left temporal (non mesial)).Continued use.

Event Description

The site reported - patient has increased serosanguinous weeping from her incision.Patient has had chills and feels somewhat achy.Patient has had intermittent fevers and is regularly taking acetaminophen and ibuprofen daily as needed for incision pain/headaches.At follow up appointment (b)(6) 2017 able to express a very tiny amount of yellowish discharge and there is very tiny pustule along side her incision.At the parietal/occipital area where the circular scab is below the eschar, the circular scab is falling off.There is a palpable enlarged tender lymph node in the right occipital area and also in the left occipital area - in comparison to (b)(6) 2017, these lymph nodes are more prominent and appear tender on palpation.Patient has good mobility of neck without discomfort.There is very mild right cheek swelling and a very mild amount of swelling above right eye - no rash noted.Treatment included: icloxacillin 500 mg bid- 6 week course.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).On (b)(6) "217" neuropace received notification from the site coordinator indicating the patient would be explanted the following day "due to the course of antibiotic treatment being ineffective." on (b)(6) 2017 neurostimulator and leads were explanted.Remote monitor was not returned.Neuropace was informed that the site may consider re-implanting the patient after the infection is resolved.On(b)(6) 2017 the explanted product was returned to neuropace for investigation.The product received included the neurostimulator, connector cover, strain relief, ferrule, ferrule clamp, three leads (one cortical strip and two depth leads) and a section of bone.There is no evidence of product failure/malfunction.Review of the dhr showed no evidence of factors that could have caused or contributed to the reported event.

Event Description

New information available.

• 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: 6481111
• MDR Text Key: 72392368
• Report Number: 3004426659-2017-00014
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170703
• 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,Followup,Followup
• Report Date: 06/30/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: 06/05/2017; 06/05/2017
• Supplement Dates FDA Received: 06/30/2017; 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 49 YR