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

Model Number	DL-330-10K
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine review of the patient's ecog in (b)(6) 2020, the treating center identified an unusual signal on the depth lead placed in the right hippocampus indicative of a lead break.Stimulation and detection were disabled at that time.Approximately one month later ((b)(6) 2020), the patient's second depth lead also showed signal activity suggestive of a lead break.Stimulation and detection were also disabled on the second lead.The patient was monitored for three months to see if the seizure frequency changed and a decision to replace the leads was made at the end of this period.On (b)(6) 2021 both leads were explanted and replaced.No information regarding seizure-related trauma or other potential causal factors resulting in the lead breaks were provided by the treating center.The newly implanted leads are functioning as intended and responsive stimulation was enabled at the time of the surgical procedure.
Additional Manufacturer Narrative
(b)(4).3004426659-2021-00021 / (b)(4).Neuropace is pending return of the explanted product.Neuropace evaluated the patient ecogs and the stimulation path impedance.The review of the patient data was consistent with a potential lead break on both leads.
Additional Manufacturer Narrative
Serial number (b)(6) -(b)(4).The lead was received by neuropace and underwent investigation.The lead was received with an end cap (manufactured by neuropace) attached about 13 cm from the distal end.Visual inspection identified that the coil appeared to be damaged under the end cap.A continuity test was performed using an ohm meter and it was discovered that the coil was completely cut under the end cap.The distal end coil of the lead was completely cut outside the area where the end cap secured the lead; the marks on the lead body (silicone) appear to have been caused by a pinching device like a "dog-bone" cranial plate.Neuropace was unable to confirm the cause of the damage to the lead coil.
Event or Problem Description
The explanted device was returned to neuropace and investigated.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 11686558
• Report Number: 3004426659-2021-00020
• Device Sequence Number: 3097373
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517210806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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
• Operator of Device: No Information
• Device Model Number: DL-330-10K
• Device Catalogue Number: 1007605
• Device Lot Number: 26361-1-1-1
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR