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

Model Number DL-330-3.5K

Device Problems Signal Artifact/Noise (1036); Break (1069); Impedance Problem (2950)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

(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.

Event 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.

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 attached about 5 cm from the distal end.The distal end coil 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 determine the cause of the damage to the lead coil.

Event Description

The explanted device was returned to neuropace and investigated.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 11686550
• MDR Text Key: 249466616
• Report Number: 3004426659-2021-00021
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005038
• UDI-Public: 010085554700503817200626
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL-330-3.5K
• Device Catalogue Number: 1007604
• Device Lot Number: 24139-1-1-1
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR