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

Model Number	DL-330-10-K
Medical Device Problem Codes	High impedance (1291); Deformation Due to Compressive Stress (2889); Impedance Problem (2950)
Health Effect - Clinical Codes	Pain (1994); Eye Pain (4467)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 10899894
• Report Number: 3004426659-2020-00058
• Device Sequence Number: 11128244
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517200130
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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
• Operator of Device: No Information
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 23327-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 40 YR