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 12/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant consisted of the rns neurostimulator and three strip leads ( port 1 cl-325-10, port 2 cl-315-10, not connected cl-325-10).

Event Description

Neuropace was informed on (b)(6) 2017 that the patient's rns neurostimulator and leads were explanted on (b)(6) 2017.Information provided by the site clarified that the explant was an intervention to an event that was initially reported to neuropace in (b)(6) 2017 (this was reported by neuropace, 3004426659-2017-00031).On (b)(6) 2017, patient experienced post-op drainage from the incision site.The patient was treated with iv vancomycin and cefepime, and on (b)(6) 2017 a surgical wound cleaning was performed.At that time, all culture results were negative and it was reported that the wound was healing well.On (b)(6) 2017 the rns neurostimulator and leads were explanted in response to a confirmed infection.The treating site categorized this as a deep incisional infection, positive for gram positive cocci.Additional information provided by the site indicates that the infection was not felt to be a result of the rns system implant.The patient had a prior history of cranial infections, developing a bone infection with a prior phase ii and resection surgery.The site believed that the infection went dormant and resurfaced after the rns system implant.

• 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: 7159991
• MDR Text Key: 96336784
• Report Number: 3004426659-2017-00061
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170706
• 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: 01/03/2018

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: 1007603
• Device Lot Number: 22951-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/03/2018
• 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: 26 YR