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 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant included, rns neurostimulator and two depth leads dl-344: port 1 left hippocampus, mesial temporal, sn (b)(4) and port 2 right hippocampus, mesial temporal, sn (b)(4).

Event Description

The patient presented on (b)(6) 2017 for a routine 6 month post op visit.She reported that she had been having some drainage from her left incision which apparently began or increased in (b)(6) after bumping her head.Examination revealed a small amount of drainage from the site of a bone marker screw.She also exhibited tenderness over the neurostimulator incision site.The patient was admitted to the hospital immediately.On more thorough examination purulent fluid was expressed from the incision site.Surgery was scheduled for the following day ((b)(6) 2017).The incision was opened, cultured, aggressively irrigated with bacitracin and peroxide and reclosed.The rns system remains implanted with stimulation enabled.Notably, the patient had been seen 1 month after surgery and had no signs of wound infection at that time.Cultures grew (b)(6) and the patient has been placed on a 6 week course of iv antibiotics.

• 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: 6986829
• MDR Text Key: 90563034
• Report Number: 3004426659-2017-00050
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170809
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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: 1007603
• Device Lot Number: 23207-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 28 YR