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

Model Number 1007610

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

(b)(6) 2015 the patient was implanted with rns sn (b)(4) and two cortical strip leads (sn b)(4) was secured to port #1 of the rns and placed in the left sub temporal region, sn (b)(4) was secured to port #2 of the rns and placed in the right sub temporal region).Both leads were secured with a titanium dog bone.The doctor placed a piece of catheter around middle of each dog bone to cushion/protect the lead.On (b)(6) 2016 during a routine review of ecogs, fce noticed abnormal looking signal / artifact on channels 1 and 2 (left sub temporal strip).The abnormal activity appears to have started on (b)(6) 2016, but possibly as early as (b)(6) 2016, but with less frequency.Patient visit on (b)(6) 2016, impedance measurements were taken and a real time ecogs was recorded.One of the impedance measurements came back as insufficient charge.During real time ecog, the site was able to palpate above the left ear and create artifact.There are 2 user saved ecogs in pdms from (b)(6) 2016 that show this phenomenon.Detection and stimulation were turned off on the left lead.The right lead has detection and stimulation enabled.(b)(6) 2016 lead revision was performed.Fce reported that the explanted lead had been secured with a titanium dog bone.Investigation confirmed two lead fractures from the explanted strip lead the first fracture appears to have been a result of the surgical explant and the second fracture was most likely a result of the use of a dogbone to secure the lead.

• 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: 6059281
• MDR Text Key: 58461474
• Report Number: 3004426659-2016-00027
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005052
• UDI-Public: 010085554700505217180709
• 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: Device Unattended
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1007610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 40 YR