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 Problems Feeding Problem (1850); Pain (1994); Chills (2191); Sweating (2444); Weight Changes (2607)

Event Date 03/03/2015

Event Type  Injury  

Event Description

(b)(6) 2014 - subject underwent their fourth neurostimulator replacement procedure.The rns system consists of neurostimulator and two cortical strip leads (cl-325-10-k).(b)(6) 2014 - the subject reported that he developed increased pain at the neurostimulator incision site.The pain gradually increased and was accompanied by chills and night sweats.Subject also reported a loss of appetite and (b)(6) weight loss over the last two months.The patient lives far from the site and was unable to find a way to get back to (b)(6) to be seen.He initially reported pain but due to the transportation issues, was seen by a local physician who felt things were fine and also removed the staples.(b)(6) 2015- subject presented to the emergency department (ed) at (b)(6) following the development of severe pain at the neurostimulator incision site.At presentation to the ed, evaluation of the wound showed "10 cm incision along the left temporal area with a small dehiscence (wound rupture along surgical suture) of apprx 3 cm associated with purulent (pus) drainage".(b)(6) 2015 - the neurostimulator and leads were explanted and sent to pathology.No indication of product failure.The rns system was detecting and delivering therapy up until the explant.The subject is a (b)(6) male with a history of hypertension, hypothyroidism, hypercholesterolemia, multiple bowel obstructions and seizure disorder.The following are the pertinent interventions to date: (b)(6) 2015 - wound culture - "light staphylococcus species and serratia marcescens," (b)(6) 2015 - subject started on vancomycin 1250 mgm bid and cefepime 2 gm tid, (b)(6) 2015 - wbc 11,000, (b)(6) 2015 - urine culture - no growth, (b)(6) 2015 - ct head - "no acute changes," (b)(6) 15 - neurostimulator & leads removed, (b)(6) 2015 - ct head(post ns removal) - "tiny collection of fluid, gas and post operative hemorrhage," (b)(6) 2015 - (b)(6) screen - negative, (b)(6) 2015 - wound fungal c/s - negative, (b)(6) 2015 - left lead/wound c/s - "very light pmns and light gnr with no organisms on gram stain," (b)(6) 2015 - picc line to be inserted.

Manufacturer Narrative

(b)(4).This patient is part of the clinical trial.5/07/2015 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 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.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 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: 4954164
• MDR Text Key: 19500278
• Report Number: 3004426659-2015-00020
• 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: 03/03/2015
• 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: 52 YR