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

Model Number 1007603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device remains implanted.

Event Description

On (b)(6) 2015 - patient was implanted with the rns system including the rns neurostimulator and three cortical strip leads.The implant occurred a week after an eight day phase ii procedure.The vns system was removed at the time of the phase ii grid placement.On (b)(6) 2015 patient arrived to the clinic and the implant incision site had drainage, the sutures were removed last week.Patient was sent to the er and will be admitted.The extent of the infection was yet to be determined.On 11/3/2015 additional information received from the doctor following surgery - there was no evidence of purulent material over the hardware and the gram stain was negative.The doctor did not remove any bone or hardware.The device did not look infected but the wound was draining.Treatment included: 6 weeks of iv antibiotics followed by oral antibiotic suppression indefinitely.

Manufacturer Narrative

(b)(6) 2016 neuropace was informed that the rns system was explanted on (b)(6) 2016, in response to the initially reported infection.Reference (b)(4).Device not returned.

Event Description

Follow-up#1, (b)(6) 2016 new information provided.

• 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: 5243907
• MDR Text Key: 31980218
• Report Number: 3004426659-2015-00030
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017151226
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 21 YR