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

Model Number RNS-320-K

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pending return of the explanted device for investigation.

Event Description

The patient's neurostimulator was initially placed on (b)(6) 2018.The patient was seen by the treating center on (b)(6) 2020, and the battery voltage of the device was measured at 2.81v.On (b)(6) 2020 neuropace became aware that the battery had reached eos (voltage was measured at 1.64v).The patient denied any medical procedures during the timeframe (b)(6) through (b)(6) which may have contributed to the rapid drop in device voltage.Initial troubleshooting was performed by neuropace on available device data, and this event was preliminarily identified as a premature battery depletion.The patient underwent a device replacement without complication on (b)(6) 2020.Pending return of the explanted product to neuropace for investigation.

Manufacturer Narrative

(b)(4).The explanted device was returned to neuropace and underwent investigation.Upon receipt, the device was found to be damaged, with a significant dent noted in the device body.Neuropace followed-up with the treating center and was unable to obtain any additional information regarding when the damage to the device may have occurred.Investigation of the device included review of device sessions, bench top testing, and opening of the device and performing detailed analysis of the neurostimulator.Electrical testing, thermal imaging and 3d x-ray and electron microscopy of the device's components were also performed.The investigation found that copper migration between layers of the printed circuit board created a resistive short circuit.This copper migration was most probably facilitated by a crack found in the board at the site of the failure.This crack was caused by mechanical damage to the neurostimulator.

Event Description

The explanted device was returned to neuropace 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 94043
• MDR Report Key: 10036414
• MDR Text Key: 202372243
• Report Number: 3004426659-2020-00016
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190924
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• 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: 26754-1-1-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 40 YR