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

Model Number DL-340 -10-K

Device Problems Improper or Incorrect Procedure or Method (2017); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted lead was returned to neuropace and an investigation was performed.The returned lead was received in two pieces and missing the proximal end.Neuropace was unable to test lead impedance on the returned pieces.Neuropace was unable to confirm the root cause of the lead break due to the incomplete product return and condition of the returned pieces.It is possible that the damage/lead break was part of the lead that was not returned.

Event Description

The patient underwent seeg localization to assist the treating clinicians in determining if the placement of the rns system leads should be revised.After completion of seeg localization, rns system impedance measurements were taken along with a real-time ecog.Impedance measurements showed insufficient charge and real-time ecog showed a flat signal.Imaging indicated that one of the seeg electrodes intersected with the rns system lead.Based on this information, the treating center identified that the seeg lead placement resulted in the break of the rns system lead.Stimulation and detection on the affected lead was disabled and the patient was scheduled for a lead revision.The affected lead was replaced on (b)(6) 2021 without complication.

• 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: 11887267
• MDR Text Key: 280681490
• Report Number: 3004426659-2021-00027
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517180414
• 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
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL-340 -10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 20319-1-1-1
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR