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

Model Number	DL-344-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine visit, a review of the patient ecog data identified signal changes, increased impedances and saturations which are indicative of a lead break.An x-ray showed a possible kink under the scalp.The lead was replaced on (b)(6) 2023.The lead was not returned for investigations.
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: 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: 17882244
• Report Number: 3004426659-2023-00048
• Device Sequence Number: 15377368
• Product Code: PFN
• UDI-Device Identifier: 00855547005014
• UDI-Public: 010085554700501417190301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 21941-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male