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

Model Number RNS-320-K

Device Problems Failure to Transmit Record (1521); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted device was returned to neuropace and is undergoing analysis.

Event Description

The patient was seen by the treating clinician on (b)(6) 2020, however during the appointment the clinician was unable to interrogate the rns neurostimulator.Interrogation was attempted with multiple tablet programmers and wands, however they were still unable to communicate with the device.Note that the patient had not been compliant with using the remote monitor as instructed and interrogating the device as prescribed prior to the appointment in (b)(6) 2020.Analysis of the most recent ecog files uploaded from the neurostimulator as of (b)(6) 2019 were analyzed, however the device was performing as expected at that time and there was no evidence of a telemetry problem.Troubleshooting was performed along with support from neuropace field clinical engineering but it was determined that the telemetry problem was unable to be resolved and the device would need to be replaced.There was no report of procedures or unusual experiences, including mri, that could have contributed to this event.The patient does experience drop seizures.The device was replaced without complication on (b)(6) 2020 and is functioning as expected.

Manufacturer Narrative

(b)(4).The findings support that the neurostimulator was damaged (dented) in an unusual location that resulted in mechanical stress and damage to the pca- printed circuit board assembly.This damage resulted in a loss of telemetry, therefore making the device unresponsive and requiring replacement.Based on the patient's seizure semiology, it is believed that the damage was a result of trauma due to a seizure.The treating center reported that the patient experiences drop seizures (which were experienced by the patient prior to implant with the rns system).

Event Description

The explanted device was returned to neuropace and investigated.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• MDR Report Key: 9875782
• MDR Text Key: 202891611
• Report Number: 3004426659-2020-00012
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190716
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 26328-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR