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

Model Number RNS-300M-K

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/04/2014

Event Type  Injury  

Event Description

(b)(6) 2014: patient implanted with neuropace neurostimulator (rns-300-m-k) and (2) neuropace cortical strip leads (cl-325-10-k) placed over the left parietal region.(b)(6) 2014: patient returned to clinic for routine rns system appointment and stated that their incision had opened in two places and was draining.Neurosurgeon placed the patient on keflex for two weeks.(b)(6) 2014: (b)(6) medical affairs had conversation with neurosurgeon regarding the infection.Neurosurgeon stated that the infection appears to be a soft tissue infection from the patient "picking" at the incision.Neurosurgeon stated that he will continue to evaluate the infection and make a decision regarding explanting after two weeks of antibiotic treatment.

Manufacturer Narrative

(b)(4).No product to be returned, product remains implanted.No report of product malfunction.Product remains implanted.

Manufacturer Narrative

(b)(4).(b)(6) 2014 - patient was seen by infectious disease physician.There was an observed improvement with the infection site it was decided to continue with the following empiric antibiotic therapy.100mg doxycycline 2x a day, 600mg rifampin 1x a day.(b)(6) 2014 - patient followed up with infectious disease physician.Patient stated for the past week there was increase in drainage from the superior wound.The plan after the appointment was to remove the implant to cure the infection.Patient was told the following plan for meds.Continue doxycycline until 7 days prior to surgery, rifampin was stopped.(b)(6) 2014 - (not sure of the specific date) - patient also met with dr (b)(6) where it was decided to remove the implant on (b)(6) 2014.(b)(6) 2014 - patient was admitted to the hospital, patient did not stop taking doxycycline.(b)(6) 2014 - rns system simulator and leads were removed.The following medication plan was followed: 1 dose of daptomycin 600mg iv prior to discharge and continue on it at home via hhn; stop cefazolin until monday dec 8 if no new culture data; rifampin 600mg oral 1x a day for 2 weeks till (b)(6).Patient was discharged on (b)(6) 2014 after surgery.Labs: source: explanted neurostimulator; gram stain: no polys, no organisms seen; culture: staphylococcus aureus; organism remark: based on staphylococcus susceptibility to oxacillin and resistance to penicillin, this isolate would be susceptible to: dicloxacillin or oxacillin/nafcillin amoxicillin-clavulanate or ampicillin-sulbactam cefadroxil, cephalexin, cefazolin, cefaclor, or cefuroxime.(b)(6) 2014 - antibiotics were changed to the following: changed to cefazolin 3gm iv q8hr instead of daptomycin.Product not returned to manufacturer.

Event Description

Follow-up report #1.

• 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: 4133644
• MDR Text Key: 4794495
• Report Number: 3004426659-2014-00008
• 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,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• 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): Other
• Patient Age: 46 YR