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

Model Number DL-330-10-K

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial implant, system included rns sn (b)(4) (right temporal) and two depth leads : port 1 - sn (b)(4) left mesial temporal and port 2 - sn (b)(4) right mesial temporal.Remains implanted.

Event Description

Lead impedance demonstrated insufficient charge.The patient was seen in clinic on (b)(6)2017.While reviewing neurostimulator data, the clinician performed electrode impedance measurements and observed an insufficient charge impedance measurement on the 4th electrode of the lead connected to port 2.This was reconfirmed with multiple impedance measurements.An x-ray of the patient's head was performed which showed that the lead in port 2 was not fully seated in the connector cover.The patient had a consult with the neurosurgeon on (b)(6)2017 and was scheduled for a revision procedure on (b)(6)2017.During the surgical procedure, the connector cover was replaced and the lead in port 2 was re-seated.Normal impedance measurements were documented post-procedure.No indication of product failure was reported.

• 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: 6689215
• MDR Text Key: 79250529
• Report Number: 3004426659-2017-00028
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517191121
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 23045-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• 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: 22 YR