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

Model Number	CL-325-10-K
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Lead migration is a potential risk as indicated in the rns® system physician manual.As indicated in the approved labeling, "the implanted lead(s) may migrate from their desired implant location.Lead migration can result in changes in detections and stimulation effectiveness, and may require additional surgical procedures to modify the lead location.".
Event or Problem Description
The patient underwent rns system placement on (b)(6) 2019.It was communicated to neuropace that the cortical strip placement was impeded during the procedure due to the stereotactic frame placement.Two ct scans were performed post-procedure and comparison of the scans indicated that the unconnected strip lead had migrated.The patient was brought back to the or for lead repositioning.No further information was provided by the treating center.

• 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: 9252349
• Report Number: 3004426659-2019-00049
• Device Sequence Number: 2448464
• Product Code: PFN
• UDI-Device Identifier: 00855547005069
• UDI-Public: 010085554700506917210717
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: CL-325-10-K
• Device Catalogue Number: 1007609
• Device Lot Number: 26319-1-1-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/29/2019
• 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
• Patient Age: 47 YR