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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 02/20/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 - patient was implanted with her fourth replacement.The rns system consisted of a neurostimulator and two connected cortical strip leads (cl-325-10 and cl-315-10).On (b)(6) 2014 - wound (surgery related) - infection (superficial) subject developed infection following routine rns replacement.On (b)(6) 2014, subject was seen by the neurosurgeon for follow up and drainage was noted.Subject was started on ten days of keflex and topical bacitracin to the wound.On (b)(6) 2014 - the subject was admitted and she had a left craniotomy with removal of the rns and leads, and debridement and washout of the wound.The wound cells grew p.Acnes and she was started on 6 weeks of vancomycin.On (b)(6) 2014 - the picc line was removed from the patient.On (b)(6) 2014 - the bacterial culture was positive for moderate escherichia coli.Subject is on oral ciprofloxacin 500 mg bid and oral amoxicillin 500 mg tid for 30 days.

Manufacturer Narrative

(b)(4).This patient is part of the clinical trial.5/12/2015 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 on 7/14/2015 neuropace, inc.Reevaluated this record.Based on internal review of the fda regulations, guidance document (draft guidance for industry and food and drug administration staff), and internal procedures, neuropace, inc.Determined that complaints associated with incision site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 explanted device and leads were returned and inspected in accordance with the decontamination process.The leads had slight damage that was attributed to the explant process, the neurostimulator device showed no evidence of damage and was successfully synchronized.There was no evidence 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.

• 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: 4954166
• MDR Text Key: 6039500
• Report Number: 3004426659-2015-00018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 29 YR