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

Model Number RNS-320-K

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Neuropace is pending return of the explanted product.Use of electrocautery is not recommended per manufacturer instructions as indicated in the approved rns system labeling.The approved labeling states: "risks regarding the use of electrocautery is addressed in the rns® system physician manual.The use of electrocautery (electro-surgery) can affect the operation of neurostimulators.The rns® system has been designed to prevent or minimize the effects of electrocautery, however the energy levels used in electrocautery can temporarily interfere with or cause permanent damage to device operation." if electrocautery is necessary, the following recommendations may be effective in minimizing potential future complications.During a surgical procedure where bipolar electrocautery is used: keep the electrocautery tip more than 2 cm (approximately one inch) from the implanted device.The selected output power of the electrocautery unit should be as low as possible for the relevant application and not used for greater than 10 seconds in any one burst.

Event Description

Telemetry with the rns neurostimulator was unable to be established following a suture removal.Troubleshooting was performed but no telemetry could be established.No information was provided as to the equipment used during the suture removal; however it is suspected that electrocautery was used, rendering the device nonfunctional.The patient underwent replacement of the device without complication on (b)(6) 2021.

Event Description

Report 3004426659-2021-00023 was originally and incorrectly reported as 3004426659-2021-00032.Report 3004426659-2021-00023 was resubmitted with the correct mfr number.Therefore this report, 3004426659-2021-00032, is being reported as a follow up.The rns neurostimulator was unresponsive when interrogated during a clinic appointment.A review of pdms indicated that the last ecog recorded and uploaded to pdms was dated (b)(6) 2021.Troubleshooting was performed in the clinic to ensure the issue was not with the rns system tablet or wand.The rns neurostimulator was replaced without complication on 5/13/2021.The patient is a resident of an assisted living facility and the facility was unable to provide any information which could help identify what might have caused or contributed to the event.Prior to this report, the patient had previously undergone a replacement procedure due to an early battery depletion (3004426659-2020-00016).

Manufacturer Narrative

(b)(4): pending return of explanted rns neurostimulator which will be investigated once returned.

Manufacturer Narrative

(b)(4).Investigation found the device to be in a state often seen after exposure to a strong field or impressed voltage such as from mri, or esu (electro-surgery).In addition, 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.The center where the patient lives did not share information about any medical procedures this patient experienced.The device was crushed at some point after explant and prior to packaging to return to neuropace.The damage was consistent with being stepped on firmly.

Event Description

Telemetry with the rns neurostimulator was unable to be established; therefore the device was explanted and 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: 11886470
• MDR Text Key: 263495647
• Report Number: 3004426659-2021-00032
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617211008
• 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,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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: 29548-1-1-1
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR