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 Unspecified Infection (1930); Pain (1994)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant.Rns system consisted of the rns neurostimulator and two depth leads: port1, (b)(4) right hippocampus, port2, (b)(4), left hippocampus.

Event Description

Neuropace was informed on (b)(4) 2017 that the patient reported pain at incision site.A wound washout / debridement was performed as it was felt that there was a possible incision site infection.No further details have been provided.

Manufacturer Narrative

On (b)(6) 2017 -the patient was admitted to the hospital and reported that she had experienced drainage from the incision site for the past 2-3 weeks.At that time the patient was started on cefepime 2g iv q8 and vancomycin 1g iv q12 for wound infection.On (b)(6) 2017, the patient was taken to the operating room for wound wash-out and implant repositioning - the skull cavity (where the rns neurostimulator was located) was expanded so that the rns neurostimulator would lie flush with the skull.Following this procedure the patient remained in the hospital and completed a four week course of vancomycin and cefepime.The rns system remains implanted and programmed for detection and treatment.The site categorized this as a superficial incisional infection.

• 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: 6970640
• MDR Text Key: 90061998
• Report Number: 3004426659-2017-00056
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170608
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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: No Information
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 22882-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/21/2017
• 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): Death; Hospitalization; Required Intervention; Disability
• Patient Age: 28 YR