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

Model Number DL-344-10-K

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

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, during patient ecog review, an unusual signal was observed on the left depth lead (implanted (b)(6) 2022).During the lead revision procedure, it was observed the lead had a physical break near the burr hole cover.Unfortunately, the surgeon cut the lead at the exact spot of the fracture.There is no indication of the cause of the lead break.

Manufacturer Narrative

(b)(4).Neuropace is pending return of the explanted product.

• 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: 18022690
• MDR Text Key: 326747978
• Report Number: 3004426659-2023-00053
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005298
• UDI-Public: 010085554700529817241027
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DL-344-10-K
• Device Catalogue Number: 1007931
• Device Lot Number: 32064-1-1-1
• Date Manufacturer Received: 10/20/2023
• 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: 44 YR
• Patient Sex: Male