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

Model Number CL-325-10-K

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

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a clinic preparation, neuropace observed electrographic signal changed to a flat line on (b)(6) 2023 on lead 2.No information was available regarding patient falls, or injuries.Impedance on contact 1 on lead 2 seemed already high at the patients last follow-up on (b)(6) 2023, though signal for lead 2 looked.On (b)(6) 2023 the programming was adjusted on the lead by disabling stimulation and a change to detection.On (b)(6) 2023, a lead revision was performed, the lead was disconnected from the neurostimulator and a previously implanted lead was then connected to 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: 18456123
• MDR Text Key: 332735145
• Report Number: 3004426659-2022-00071
• Device Sequence Number: 1
• Product Code: PFN
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CL-325-10-K
• Device Catalogue Number: 1007933
• Device Lot Number: 31247-1-1-1
• Date Manufacturer Received: 11/07/2023
• 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; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Male