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

Model Number RNS NEUROSTIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Date 04/17/2015

Event Type  Injury  

Event Description

(b)(6) 2014 - the subject was implanted with a neurostimulator device and two depth leads (dl-330-10-k and dl-330-3.5-k).(b)(6) 2015 the fce (field clinical engineer) spoke to the nurse, she indicated the subject reported some drainage of clear fluid from the incision.Subsequently the patient was examined by a physician who prescribed antibiotics.(b)(6) 2015: the subject underwent a debridement procedure.The implanted hardware was left in place.Pathology did not identify an infectious organism.(b)(6) 2015: the subject was examined by another doctor.Clear drainage was present at the incision line.The doctor counselled the subject and a decision was made to remove the implanted hardware and plan for a potential re-implantation in several months.(b)(6) 2015: the implanted hardware was removed.Pathology results did not identify an infectious organism.

Manufacturer Narrative

(b)(4).5/08/015 neuropace, inc.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.6/25/15 neuropace, inc.Reopened and reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with incision site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.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.Device not returned.

• 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: 4954510
• MDR Text Key: 6636537
• Report Number: 3004426659-2015-00006
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/27/2015

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: 04/17/2015
• 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: 55 YR