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 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient reported having issues interrogating the rns neurostimulator on (b)(6) 2019.Up until that date, the patient had not experienced any problems.The patient was provided with a new rns system remote monitor and wand; however the telemetry problem continued to persist.The patient was seen for an appointment on (b)(6) 2019, no telemetry was able to be established with the rns neurostimulator.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 and there was no evidence of a telemetry problem.The patient and caregiver denied any seizure-related trauma, medical procedures, or any other possible interactions occurring near the neurostimulator implant site between (b)(6).The treating center made several attempts to schedule the device replacement with the patient, however the patient was unable to attend until (b)(6) 2020.The rns neurostimulator was replaced on (b)(6) 2020 without complication.

Manufacturer Narrative

(b)(4).Telemetry with the rns neurostimulator was unable to be established; therefore the device was explanted and returned to neuropace for investigation.Analysis of available rns neurostimulator data on pdms showed no abnormalities.When received at neuropace, telemetry was still unable to be established with the device.Investigation identified low battery voltage and collapse of an internal supply component which is consistent with exposure to high energy [such as an electrosurgical unit (esu)].As previously reported, the patient and caregiver denied any seizure-related trauma, medical procedures, or any other possible interactions occurring near the neurostimulator implant site between july 17 and 18 which may have involved esu.Therefore, the cause of the telemetry issue remains undetermined.

Event Description

The explanted device was received by neuropace on 10 feb 2020 for investigation.

• 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: 9782498
• MDR Text Key: 202890637
• Report Number: 3004426659-2020-00005
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717200312
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• 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: 27693-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR