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

Model Number	CL-325-10
Medical Device Problem Codes	Break (1069); Impedance Problem (2950)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for investigation.Review of the lead impedance and ecog data was performed and the data is consistent with a lead break.Unable to determine root cause of the lead break.
Event or Problem Description
During a review of rns neurostimulator data by the treating clinician, artifact was observed on the ecog recorded from the left strip lead , indicating a potential lead break.After discussion with the patient, it was determined that this signal change occurred following a fall due to a seizure, consistent with the patient's pre-implant seizure semiology.The patient was subsequently scheduled for a lead replacement procedure, which was performed without complication.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view, ca
• MDR Report Key: 10387984
• Report Number: 3004426659-2020-00026
• Device Sequence Number: 11190630
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917210123
• Combination Product (Y/N): N
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: CL-325-10
• Device Catalogue Number: 1007609
• Device Lot Number: 25330-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/10/2020
• 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: Other
• Patient Age: 55 YR