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 No Consequences Or Impact To Patient (2199)

Event Date 06/23/2014

Event Type  Injury  

Event Description

(b)(6) 2014 - the subject underwent her third neurostimulator replacement procedure.The rns system configuration for this subject includes a neurostimulator and two cortical strip leads (cl-315-10).(b)(6) 2014 - intraoperative (routine rns replacement) swab cultures of ferrule after the removal of the subject's neurostimulator grew propionibacterium acnes as well as staphylococcus capitis.The patient is asymptomatic.Patient states she was told she would not need any additional treatment at this time other than the routine post-op antibiotics that she took.No indication of product failure.Patient was treated for infection with antibiotics.Anticipated risk associated with craniotomy.

Manufacturer Narrative

Reference (b)(4), this patient is part of the clinical trial.(b)(6) 2015 during the adverse event review for the pas study it was identified that this event had not been reviewed according to the complaint handling process.Once identified this record was generated to meet the complaint review process.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 (b)(6) 2015 neuropace, inc.Reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with incision site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.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: 4954174
• MDR Text Key: 6039950
• Report Number: 3004426659-2015-00016
• 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: 07/17/2015

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: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 07/30/2015
• 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: 45 YR