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

Model Number DL-330-10-K

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient was initially implanted on (b)(6)2014.The initial implant consisted of rns 189132, and four leads including: port1, dl-330-10, 189603, left mesial temporal, secured with burr hole.Port2, dl-330-10, 189498, right mesial temporal, cl-325-10, 189152, left sub temporal.Not connected, cl-325-10, 189152, left sub temporal.Not connected, cl-325-10, 189395, right sub temporal.Current rns 195854 was implanted on 5/10/2017 , this is the patient's second rn.Sproduct discarded.

Event Description

Ecog artifact was observed suggesting lead break.Surgery was performed to replace the depth lead, at that time it was observed that the rhi depth lead had a visible fracture at the point where it exited the burr hole cover.The lead was secured with a burr hole cover manufactured by np.The rns device was also replaced at this time.

Manufacturer Narrative

(b)(4).

• 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: 6614511
• MDR Text Key: 76748071
• Report Number: 3004426659-2017-00023
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• 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: 1007438
• Device Lot Number: 18525-1-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• 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; Other
• Patient Age: 62 YR