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

Model Number CL-335-10-K

Device Problems Signal Artifact/Noise (1036); Impedance Problem (2950)

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

During an ecog review performed on 08/09/2022, an unusual signal was observed, indicative of a lead break on the right sub-temporal strip.The break appears to have occurred around feb 2022.There was no change in treatment, the doctor reported that the fracture did not seem to affect efficacy of the rns system.Troubleshooting included palpitation of the lead which resulted in high impedance and signal artifact.No known trauma was reported, and a cause was unable to be determined.The lead was secured with a burr hold cover.The lead has been implanted 1.7 years at time of lead break observation.On (b)(6) 2023 the patient underwent a lead revision.

Manufacturer Narrative

(b)(4).The lead remains implanted but disconnected from the rns.

• 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 ; 5108822607
• MDR Report Key: 16769935
• MDR Text Key: 313742137
• Report Number: 3004426659-2023-00015
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005304
• UDI-Public: 010085554700530417230226
• 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
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CL-335-10-K
• Device Catalogue Number: 1007934
• Device Lot Number: 29716-1-1-1
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male