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

Model Number RNS-300M-K - FGI

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

Patient Problems Discomfort (2330); Neck Pain (2433)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient was implanted with the rns system including four depth leads dl-344-10, port 1, left mesial temporal (suspected lead break).Dl-330-10, port2, right mesial temporal dl-330-10, right para-hippocampus, not connected.Dl-344-10, left para hippocampus, not connected.Product remains implanted.

Event Description

The patient reports a shocking sensation and muscle tightening in the neck whenever the device delivers therapy.He was on a lead-to-lead (l hippocampus - r hippocampus) therapy pathway at 2.8 uc (burst 1) and 2.5 uc (burst 2) current density.The patient reported that he experienced a shocking sensation when the device delivered therapy and when interrogating, this has been occurring since (b)(6) 2014, when therapy was activated.The site performed blinded therapy testing during clinic that corroborated the patient's experience when stimulation is delivered.The polarity was changed, this seemed to make the shocking sensation go away during therapy testing.Patient states he can still feel the shocking sensation when he interrogates but no longer randomly throughout the day, when he is likely receiving therapy.(b)(6) 2017 follow-up appointment attended by company representative dr.(b)(6) performed the unipolar study on the 4 electrodes on lead 2 (rh) to test which electrode(s) give the "shocking" sensation.Electrode 1 - felt sensation 50% of testing.Electrode 2 - no sensation.Electrode 3 - no sensation.Electrode 4 - no sensation.Electrode 1 was taken out of the therapy pathway.Electrodes 2, 3, and 4 were programmed negative to the can (0 - - -) (+).Patient did not report feeling the sensation during therapy testing.

• 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: 6629718
• MDR Text Key: 77277654
• Report Number: 3004426659-2017-00024
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RNS-300M-K - FGI
• Device Catalogue Number: 1007427
• Device Lot Number: 18426-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• 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): Other
• Patient Age: 27 YR