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

Model Number DL-344-3.5-K

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient was initially implanted (b)(6) 2009 with two depth leads and the original rns device.The patient has had a total of three rns devices ( the initial implant and two replacements due to normal battery depletion).Product discarded.

Event Description

(b)(6) 2017 right depth lead replacement right mesial temporal.(b)(6) 2016 patient had scheduled neurostimulator replacement.At the time of replacement, rh (lead 1 sn (b)(4)) impedances were >3000 ohms or "insufficient charge".Troubleshooting was performed including; cleaning leads, removing connector cover and irrigating, changing connector covers, swapping leads - there was no change to lead impedance measurements from that lead.Also tried plugging in the old device, but same results as with the new device.Real time ecog looked fine, so closed.(b)(6) 2016 follow up visit.Detailed therapy testing on the right hippocampal lead was completed and patient reported no sensitivity.Palpitation near the lead was done while running real-time ecog, and there was some artifact present in the ecog.The device was reprogrammed to remove the stimulation from lead 1 (rh).(b)(6) 2017 the right depth lead was replaced (sn (b)(4), right mesial temporal) to address the high impedances.The lead was discarded by the site.

• 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: 6502582
• MDR Text Key: 73092923
• Report Number: 3004426659-2017-00018
• 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: 04/12/2017

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: DL-344-3.5-K
• Device Catalogue Number: 1006197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/18/2017
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 47 YR