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

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Irritation (1941); Seizures (2063); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 04/15/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 - the patient was implanted with neurostimulator and two depth lead (dl-344-10-k).The leads were placed in the left and right mesial temporal region.On (b)(6) 2015 - the patient's father sent an email to (b)(6) stating "the patient's mental state has deteriorated considerably.He has awakened us the last three nights with 'voices' that tell him things that are concerning".Patient was "admitted through the er soon after his implant for seizures clustering, high fever and confusion - he was found to have pneumonia." on (b)(6) 2015 - (b)(6) emailed the fce stating "we think all the episodes were related to the pneumonia.The device, etc are fine and currently the patient is back to his baseline." on (b)(6) 2015 (b)(6) emailed the fce saying "it seems i was incorrect, the patient, was not only diagnosed to have pneumonia.Dr.(b)(6) said he was having clusters of seizures as well which made him confused and unable to function which could have been attributed to irritation caused from the neuropace implant." on (b)(6) 2015 - the patient was not admitted to the hospital after that one hospitalization incident as reported.The neurostimulator was not enabled.The patient has been seen for three follow-ups since then ((b)(6)) with therapy enabled at the first follow-up.The patient's family has been reporting an improvement in the patient's mood, etc.The rns system is currently programmed for detection and therapy.No report of product malfunction.The rns neurostimulator and leads remain implanted for detection and treatment of epilepsy.The patient's family has been reporting an improvement in the patient's mood, etc.Medical affairs review: seizures post-op are attributed to surgical procedure and an anticipated event following any intra-cranial procedure.

Manufacturer Narrative

(b)(4).Device remains implanted.

• 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: 4929824
• MDR Text Key: 6435114
• Report Number: 3004426659-2015-00012
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/21/2015
• 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
• Patient Age: 36 YR