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

Model Number	DL-330-10-K
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The explanted lead was not returned to neuropace for analysis.However, review of the device ecog and lead impedance confirmed that the ecog data are suggestive of a potential lead break.
Event or Problem Description
A signal artifact was noted on the recorded ecogs during a follow-up appointment on (b)(6) 2019 for the left depth lead.The patient was referred for x-rays (negative for evidence of a lead break) and neurosurgical consult.A lead revision was performed on (b)(6) 2019; however lead impedances were unable to be measured pre-op.Various troubleshooting steps were performed during the procedure, however the lead impedances were still unmeasurable.A kink was noted in the region of the lead body near the dog bone.Once the lead was straightened, the lead was re-tested; however no impedance measurements were able to be obtained.The lead was explanted and a new lead was implanted, connected and tested with no issue.Hospital policy requires explanted devices due to non-routine causes to be given to the risk management department for analysis.Therefore the explanted device is unable to be returned to neuropace at this time.

• 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: 9612641
• Report Number: 3004426659-2019-00066
• Device Sequence Number: 16813646
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517220312
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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: 27657-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/21/2020
• 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: 32 YR