MAUDE Adverse Event Report: NEUROPACE,INC NEUROPACE RNS SYSTEM

Model Number RNS-300M-K

Device Problem Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial implant was performed on (b)(6) 2017.The system included the rns neurostimulator, sn (b)(4); two depth leads dl-344-10.Port 1, sn (b)(4), left mesial temporal.Port 2, sn (b)(4), right mesial temporal.

Event Description

On (b)(6) 2017, neuropace field clinical engineers noted abnormal impedances on the right depth lead connected to the neurostimulator on port 2.The interrogation report on pdms displayed insufficient charge and low impedances.The site originally assumed that this was a result of the distal portion of the lead being placed in csf of a large ventricle.However the treating clinician ordered a head x-ray to determine if the lead was properly seated within port 2 of the neurostimulator.The x-rays were reviewed by both the treating clinician and neuropace.While no clinical abnormalities were noted, neuropace did note that there was possible evidence indicative of potential misalignment that would be consistent with the abnormal impedances measured on that lead.No further action was taken by the treating site at that time.On (b)(6) 2017, the patient underwent an exploratory surgery to establish the cause for the abnormal impedance measurements on the right depth lead.Upon opening and exposing the lead and connector cover, the surgeon established that all contacts on the lead were not fully seated in the connector cover.A new connector cover was attached to the neurostimulator and the leads were re-connected.Impedances and real-time ecogs were taken.Impedance measurements were all within the normal range and the ecog signal looked electrographic in nature.A second impedance measurement and real-time ecog were taken after the wound was closed and all measurements remained in good standing.A review of the neurostimulator data in pdms identified that no impedance measurements were performed at the time of the initial implant; therefore there were no baseline impedances to compare against.

• 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: 7113789
• MDR Text Key: 94736752
• Report Number: 3004426659-2017-00059
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005120
• UDI-Public: 010085554700512017170703
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RNS-300M-K
• Device Catalogue Number: 1007603
• Device Lot Number: 22950-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2017
• 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
• Patient Age: 38 YR