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

Model Number DL-330-10-K

Device Problems High impedance (1291); Impedance Problem (2950)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).3004426659-2021-00009 / (b)(4).Review of the lead impedance and ecog data was performed and the data is consistent with a lead break.The explanted product was not returned to neuropace for analysis.

Event Description

A routine data review of the patient's data in pdms indicated that the lead connected to port 1 demonstrated artifact and insufficient charge during impedance measurement, suggestive of a lead break.On (b)(6) 2019, detection was disabled for the lead in port 1 and the patient continued to receive treatment via the lead connected in port 2.In (b)(6) 2020 it was noted via a review of the patient's data in pdms that the lead connected to port 2 also began demonstrating intermittent artifact, although impedances were within the normal range, suggestive of a lead break.Once the second break was noted, the patient was scheduled for a surgical procedure to replace both leads connected to the rns neurostimulator.Upon explant, a break was visibly apparent in both leads, the leads were kinked at the point they were anchored to the skull via a dog-bone plate (non-neuropace product).No complications were reported during the surgical procedure and the patient is currently receiving treatment with the rns system.

• 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 ; 6502382788
• MDR Report Key: 11441117
• MDR Text Key: 274791554
• Report Number: 3004426659-2021-00008
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517211108
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 27037-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• 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): Other
• Patient Age: 49 YR