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

Model Number	CL-335-10-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Twiddlers Syndrome (4563)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.
Event or Problem Description
The physician reported that the patient was picking at the rns system incision site and a portion of an unconnected rns system lead was exposed.There was some evidence of erosion at the incision site; however it is unclear if this was due to the excoriation of the incision site.Once exposed, the patient cut the lead near the dog-bone plate (a non-neuropace product used to secure the lead to the skull), removed the exposed portion of the lead, and discarded the product.The residual portion of the cut lead remains implanted.As the lead was not connected to the rns system, the patient's responsive stimulation treatment was not affected by the event.Treatment included wound cleaning and antibiotics.

• 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: 11405447
• Report Number: 3004426659-2021-00007
• Device Sequence Number: 14585875
• Product Code: PFN
• UDI-Device Identifier: 00855547005052
• UDI-Public: 010085554700505217210628
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2021
• 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): 03/03/2021

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-335-10-K
• Device Catalogue Number: 1007610
• Device Lot Number: 26294-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/03/2021
• 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: 28 YR