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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Test Result (2695)

Event Date 07/08/2015

Event Type  Injury  

Event Description

(b)(6), 2010: patient was implanted with the neuropace rns neurostimulator and neuropace cortical strip leads ((b)(4)), (b)(6), 2015: patient was scheduled for routine neurostimulator replacement as neurostimulator had reached elective replacement.During surgery the neurosurgeon noted signs of a possible infection.The rns system was explanted and three sample cultures were taken and sent to pathology.Patient was placed on iv cefazolin q 8 hours.(b)(6), 2015: laboratory results indicated that one of the three cultures was positive for gram positive cocci-suspect coag negative for staphylococcus.Patient will continue outpatient treatment plan as outlined pending final results.

Manufacturer Narrative

(b)(4), this is a study patient.On (b)(6) 2015, the physician implanted the second replacement device in an alternative unapproved location using off label leads.Sterility record review performed.Sterilization results met requirements as specified in the specifications.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: 4974386
• MDR Text Key: 6360765
• Report Number: 3004426659-2015-00011
• 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: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR