MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Purulent Discharge (1812); Staphylococcus Aureus (2058)

Event Date 01/27/2015

Event Type  Injury  

Event Description

(b)(6) 2014 - subject underwent her third neurostimulator replacement procedure.The rns system consists of a neurostimulator, a connected depth lead (dl-330-10) and a cortical strip lead (cl-315-10).(b)(6) 2015 - subject noted a small depression in the area of the neurostimulator implant.It was initially tender to touch and cyst-like, then it "popped", releasing waxy material and now leaving a depression at the site of the previous cyst.The depression is still there and cultures positive for staph aureus.Antibiotic treatment was started.(b)(6) 2015 - the ferrule was replaced to allow treatment of the infection.In addition antibiotics were introduced into the incision site as an additional measure to treat the infection.The rns system remains implanted and both therapy and detection are enabled.

Manufacturer Narrative

(b)(4), this patient is part of the clinical trial.Udi - na.(b)(4) 2015 (b)(4) voided this complaint.There was no reported product malfunction and no indication the product contributed to the infection.Infections are anticipated when performing craniotomy procedures.(b)(4) 2015 neuropace, inc.Reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with incision site infections are reportable.These past events show no indication that the product caused the infection and there is no indication of product failure.The rns system remains implanted and is programmed for detection and therapy.Sterility record review performed.No evidence of factors that could have caused or contributed to the reported event.All sterilization results met requirements as specified in the specifications.Product remains implanted.

• 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: 4954153
• MDR Text Key: 6039023
• Report Number: 3004426659-2015-00019
• Device Sequence Number: 1
• Product Code: PFN
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2015
• 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): Required Intervention
• Patient Age: 46 YR