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 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

Event Description

Neuropace was notified that the treating clinician was reporting unspecified difficulties interrogating the patient's rns neurostimulator using the rns® tablet during a clinic appointment.Further troubleshooting was performed, including the use of different rns® tablet and wands to interrogate, however the rns neurostimulator was still unable to be interrogated.The treating clinician and patient stated that the device had not been exposed to mri or any surgical procedures involving the use of electrocautery.Review of device data indicated that the device was functioning normally as of (b)(6) 2019.However, no further data or communication with the device was present after that date.The patient was subsequently scheduled for a neurostimulator replacement procedure on (b)(6) 2020 which occurred without complication.

Manufacturer Narrative

An investigation was performed on the available neurostimulator data stored in pdms.The data from the device indicated that the device was functioning as intended prior to the most recent interrogation of (b)(6) 2020.The returned rns neurostimulator was received at neuropace severely damaged (crushed), resulting in the inability to perform a physical analysis.Reports from neuropace personnel present during the explant procedure indicate that this damage occurred at the treating center, and occurred after explant but before the device was packaged to be returned to neuropace.The source of this damage is unknown and the extent of this damage makes further investigation of the complaint for lack of telemetry unfeasible as damage from bending of the pca would mask the reported problem.

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 CA 94043
• MDR Report Key: 9612597
• MDR Text Key: 176209367
• Report Number: 3004426659-2019-00060
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190403
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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: 25944-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 30 YR