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

Model Number RNS NEUROSTIMULATOR

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Inflammation (1932); Seizures (2063); Therapeutic Effects, Unexpected (2099); Convulsion, Tonic (2223); Therapeutic Response, Decreased (2271)

Event Date 06/10/2015

Event Type  Injury  

Event Description

(b)(6) 2015 patient was implanted with a neuropace neurostimulator and two neuropace depth leads (dl-330-10-k) placed in the right and left hippocampus.(b)(6) 2015 rns system is programmed with detection enabled, stimulation disabled.(b)(6) 2015 rns system is programmed with detection and stimulation enabled.(b)(6) 2015 patient was admitted to the hospital in status epilepticus.Rns system is programmed with detection and stimulation enabled.(b)(6) 2015 the fce received an email from (b)(6) stating that the patient "is again having uncontrolled seizures and is being readmitted".(b)(6) 2015 rns system programmed with detection enabled and stimulation disabled.(b)(6) 2015 (b)(6) md/cmo from neuropace spoke with dr.(b)(6) at (b)(6) by telephone about the patient being treated with the rns system who has required an admission to the hospital due to seizures.The information from dr.(b)(6) is as follows: the patient is a woman (b)(6) who has a 12 year history of epilepsy that occurred in association with a febrile illness and a presumed infection.Her first seizure was convulsive status epilepticus and she has been treated subsequently with a number of different antiepileptic medications but has never achieved seizure control.Her seizures have almost all been complex partial since her initial seizure.She also has cognitive difficulties which require that she be cared for in a nursing facility.These have been present and stable for some time.Dr.(b)(6) is not certain about the etiology of her cognitive impairment but believes it is related to the infection that is assumed to be the etiology of her epilepsy.The patient has seizures that arise independently from the left and right mesial temporal regions as documented by video-eeg monitoring.She was implanted on (b)(6) 2015 with an rns neurostimulator and neuropace depth leads, one in the left and one in the right hippocampus.The surgery was uneventful and she was discharged soon after the implant.The rns neurostimulator was programmed to detect but stimulation was not enabled.She returned to the hospital 10 days after the implant procedure because of frequent seizures.Scalp eeg showed electrographic seizures.A head ct showed no acute changes other than the two depth leads; specifically there was no hemorrhage.She was placed on steroids for presumed inflammation related to the lead implants and was discharged the next day.She returned to his clinic on (b)(6) (his estimate of the date) and was doing well so he enabled responsive stimulation.The neurostimulator was programmed to deliver a charge density of 0.8 uc/cm2.Within several days, she had 2 generalized tonic clonic seizures, which is unusual for her.Therefore she was readmitted on (b)(6) and the responsive stimulation was turned off.The scalp eeg he obtained showed near continuous spiking in the right temporal region which he believes is not typical of her eeg.She did not have seizures in the hospital and was discharged - he believes this was the next day.On (b)(6) she was readmitted because of frequent seizures.Stimulation remained off.At the time of our conversation, he had not yet seen the patient but believed that she had not had seizures since admission the day before.He asked whether we'd had similar experiences with patients participating in the trials and i responded that we have not.We discussed treatment options, including explantation of the rns neurostimulator and one or both neuropace leads.He prefers to leave the neurostimulator and both leads implanted.He intends to obtain another ct scan and to treat her with a second course of steroids.He will also be monitoring her with scalp eeg.She is medically stable and at her cognitive baseline.(b)(6) 2015 patient was implanted with a neuropace neurostimulator and two neuropace depth leads (dl-330-10-k) placed in the right and left hippocampus.(b)(6) 2015 patient was admitted to the hospital in status epilepticus.The event was not deemed to be device related as therapy was off.On (b)(6) 2015 the fce received an email from (b)(6) stating that the patient "is again having uncontrolled seizures and is being readmitted".(b)(6) 2015 the rns system is currently programmed for detection only and therapy is currently disabled.

Manufacturer Narrative

(b)(4).Device remains implanted.

Manufacturer Narrative

The event date was incorrectly entered.Event date is estimated to be (b)(6) 2015.(b)(4).Device remains implanted.

Event Description

Follow-up1.

• 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: 4946135
• MDR Text Key: 6254760
• Report Number: 3004426659-2015-00010
• 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,company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• 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: 06/29/2015
• 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: 56 YR