MAUDE Adverse Event Report: NEUROPACE,INC NEUROPACE RNS SYSTEM

Model Number DL-330-10-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

On 08/21/2017 this was the patient's first rns system implant.The implant included the rns neurostimulator and four depth leads (all were secured via dog bone plates).

Event Description

An abnormal signal was observed on the depth lead connected to port 2 of the rns neurostimulator on (b)(6) 2017 during a review of the patient's ecog data on the patient data management system (pdms).During the next patient appointment, initial troubleshooting was performed and the patient interviewed to determine if any contributing factors could be identified relating to the appearance of the abnormal signal.The patient stated he did not recall falling however he states that he may have fallen as he tends to fall with his seizures and does not always remember or is unaware when his seizures occur.A lead revision was subsequently performed on (b)(6) 2017 during which additional troubleshooting and connector cover/port cleaning were conducted.No product was explanted during the procedure; however a new depth lead was implanted and connected to port 2.

• 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 ; 6502372788
• MDR Report Key: 7206236
• MDR Text Key: 97764143
• Report Number: 3004426659-2018-00002
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517190628
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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: 22344-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR