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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Discharge (2225)

Event Date 01/08/2014

Event Type  Injury  

Event Description

(b)(6) 2013, subject underwent fourth neurostimulator replacement procedure.The rns system consists of the neurostimulator, two connected depth leads (dl-330-10 and dl-344-3.5) and two cortical strip leads (cl-325-10, not connected).(b)(6) 2014, subject was seen by the neurosurgeon for follow up and drainage was noted from the incisional site.Subject was started on seven days of keflex po and topical bacitracin to the wound.(b)(6) 2014, subject called in to say that the wound was weeping at the incision site.(b)(6) 2014, subject was seen by the neurosurgeon and another 1 week course of keflex po was started, and bacitracin was continued.(b)(6) 2014 subject noted that wound was scabbed over and the wound drainage had stopped.The rns system remains implanted and programmed for detection and therapy.

Manufacturer Narrative

(b)(4), this patient is part of the clinical trial may 12, 2015 during the adverse event review for the (b)(4) 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 july 14, 2015 neuropace, inc.Re-evaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with incision site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: 4954201
• MDR Text Key: 6039505
• Report Number: 3004426659-2015-00015
• 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

• 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: 01/08/2014
• 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