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

Model Number RNS-320-K

Device Problems Failure to Interrogate (1332); Failure to Transmit Record (1521); Communication or Transmission Problem (2896)

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

Event Date 12/30/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, during a scheduled resection procedure the rns was rendered unresponsive after the use of esu.Because of the patient infection risk factor the doctor choose to only perform the resection.On (b)(6) 2021 the doctor replaced the damaged rns neurostimulator and revised the lead that was previously located in the resected area.

Manufacturer Narrative

(b)(4).The explanted device was received by neuropace and is undergoing analysis.

Event Description

On (b)(6) 2021, during a scheduled resection procedure the rns was rendered unresponsive after the use of esu.The explanted neurostimulator was returned to neuropace and investigated.

Manufacturer Narrative

(b)(4).The device experienced a por (power on reset) due to esu exposure on (b)(6) 2021 causing the device to not support normal telemetry while the reset and recovery was in process.The device had recovered by the time it was received by neuropace for analysis use of electrocautery is not recommended per manufacturer instructions as indicated in the approved rns neurostimulator and leads labeling.The use of electrocautery (electrosurgery) 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.Electrocautery applied near the rns® neurostimulator may cause it to temporarily stop sensing, delivering therapy, or may reset the neurostimulator.Under these conditions the neurostimulator may require interrogation and possible reprogramming.Electrocautery applied directly to the neurostimulator or leads may couple enough energy into a neurostimulator system to damage brain tissue.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 6502382788
• MDR Report Key: 13315252
• MDR Text Key: 288509482
• Report Number: 3004426659-2021-00061
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617211021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30702-1-1-1
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male