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

Model Number DL-330-10-K

Device Problems High impedance (1291); Deformation Due to Compressive Stress (2889); Impedance Problem (2950)

Patient Problems Pain (1994); Eye Pain (4467)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of the lead impedance and ecog data was performed and the data is consistent with a lead break.Investigation of the returned explanted lead suggests that lead damage was caused by the possible use of a titanium cranial plate (non-neuropace product) to secure the lead (commonly referred to as a "dog bone").Neuropace was unable to conclusively determine the root cause of the lead break.

Event Description

In (b)(6) 2020 the patient reported feeling an electric shock sensation around his right eye.The treating clinician, in conjunction with neuropace field support, reviewed the patient's ecogs and identified artifact which was indicative of a lead break on the left depth lead.The clinician reprogrammed the lead and the patient reported a decrease in the frequency and severity of the sensation.In (b)(6) 2020, the clinician disabled detection and stimulation in the left depth lead which was successful in eliminating the sensation.A lead replacement was performed in (b)(6) 2020 and a new lead was implanted and connected to the neurostimulator.After the replacement there have been no reports of painful sensation and the lead is functioning as intended, per the treating clinician.

• 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: 10899894
• MDR Text Key: 220532093
• Report Number: 3004426659-2020-00058
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517200130
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 23327-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• 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; Other
• Patient Age: 40 YR