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

Model Number	DL-330-10-K
Medical Device Problem Codes	High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
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.Neuropace received only the proximal end of the explanted lead for investigation.The portion of the lead received was received damaged and the coil was stretched.No wire breaks were found on the portion of the lead that was received, all 4 wires passed continuity test.Unable to determine root cause of the lead break.
Event or Problem Description
A review of the recorded ecog data and impedance measurements on pdms confirmed high impedances and signal artifact on the left depth lead, suggestive of a lead break.It was unclear exactly when the changes occurred between february and june as the patient was not regularly using his remote monitor.The patient did not recall falling in between the time that the signal changes were noted on the depth lead.A lead replacement was performed and a portion of the explanted lead was discarded by the hospital.A new lead was implanted and connected to the rns neurostimulator without complications and is functioning as intended.

• 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: 10782188
• Report Number: 3004426659-2020-00052
• Device Sequence Number: 1138202
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517210327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/04/2020

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: 25686-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 11/03/2020
• 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: 22 YR