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

Model Number RNS-300M-K

Device Problem Insufficient Information (3190)

Patient Problem Seizures (2063)

Event Date 08/02/2014

Event Type  Injury  

Event Description

(b)(6) 2014: patient underwent implantation of an rns neurostimulator and two bilateral depth leads placed in each of the hippocampi along with 2 bilateral cortical strip leads placed over the lateral aspect of the temporal lobe.Ecog signals and lead impedances were verified in the operating room and were within acceptable ranges.Responsive stimulation was not programmed on.(b)(6) 2014: patient experienced a paranoid psychotic episode requiring haldol and physical restraints.Patient will be transferred to a psychiatric unit if no improvement.The rns system was interrogated and no seizure activity was detected by the neurostimulator during a nonepileptic shaking event.Responsive stimulation was not programmed on.(b)(6) 2014: patient reported doing much better as communicated by the treating physician, (b)(6).(b)(6) stated that the patient, "much better, getting back to normal.Had a seizure last night, i adjusted the detection settings." (b)(6) 2014: patient discharged from hospital on (b)(6) 2014 per (b)(6).Responsive stimulation was programmed enabled on (b)(6) 2014 and the patient was instructed on use of the remote monitor.Psychiatric issues appear to be resolved.(b)(6) 2014: the neuropace field clinical engineer (fce) reported that the neurosurgeon had verbally communicated to her that the psychotic episode was a result of the surgery and not the rns system.(b)(6) 2014: the neuropace rns system is performing as expected.The implanted neurostimulator is currently activated for detection and delivering therapy according to the doctors programming.(b)(6) 2014: there were no non-conformances reported for the neurostimulator nor the implanted leads.

Manufacturer Narrative

Device remains implanted in patient.

• Brand Name: RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo avenue; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo avenue; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave; mountain view, CA 94043 ; 6502372388
• MDR Report Key: 4045284
• MDR Text Key: 4804230
• Report Number: 3004426659-2014-00005
• 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: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: RNS-300M-K
• Device Catalogue Number: RNS-300M-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• 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: 59