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

Model Number DL-344-3.5-K

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2016 patient was implanted with the rns system including two depth leads (sn (b)(4) left mesial temporal and (b)(4) right mesial temporal).Both leads were secured with dog bones.This record is associated with 3004426659-2017-00005.Product damaged during explant.

Event Description

On (b)(6) 2016 the patient ecogs were reviewed and square signals were observed on channels 1 and 2 (sn (b)(4)) additional testing of the lead impedances revealed insufficient charge and irregularity in the lead signal.Based on troubleshooting it was believed that the irregular signal was a result of a lead break.There was no indication of signal issue with the right lead at that time.The left lead detection and therapy were disabled.On (b)(6) 2016 the patient returned for follow up.It was noted that the left depth lead issues continued and impedances/ecog signals were abnormal.It was brought to dr.(b)(6) attention that on ~(b)(6) 2016 there was artifact seen on the right depth lead (sn (b)(4)) as well and impedance checks revealed that there was 'insufficient charge' on contact rhip4.Dr.(b)(6) counseled the patient on replacing both leads as she felt the troubleshooting indicated both leads were possibly fractured.On (b)(6) 2016- during the surgical case, after exposing the device, the left and right depth leads were removed from their original ports and placed in the opposite ports.(left depth=port2 / right depth=port1) impedances and ecog signals were then checked and it was verified that the abnormal impedances and artifactual signals followed the lead swap.This confirmed the issue was with the leads and not the ipg itself.Both leads were then explanted and sent to pathology.New leads were implanted and all impedances were wnl(within normal limits).Ecog signals were appropriate per dr.(b)(6).Leads will not be returned for investigation they were both stretched/damaged during the explant process.

• 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: 6279245
• MDR Text Key: 65829397
• Report Number: 3004426659-2017-00003
• Device Sequence Number: 1
• Product Code: PFN
• 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: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DL-344-3.5-K
• Device Catalogue Number: 1007439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2016
• 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: 49 YR