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

Model Number	DL-330-10-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Peripheral Nervous Injury (4414)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted lead was not returned to neuropace.
Event or Problem Description
The patient underwent initial placement of the rns system in (b)(6) 2020.Starting (b)(6) 2021, the patient reported a sensation of pain around the incision.The area was palpated by the epileptologist and an x-ray was performed; however no cause for the source of pain was identified.On (b)(6) 2021, the patient underwent exploratory surgery.No signs of infection or issues with product fixation were noted.The lead fixation plate was replaced prophylactically and a small amount of bone was smoothed to allow the lead located closest to the area of the pain to sit flush.On (b)(6) 2021, the treating epileptologist reported that the pain was still ongoing.The patient underwent unknown pain control injections at their primary physician's office (date and type of injection not reported).On (b)(6) 2021, the patient was seen by the treating clinician and reported that the pain continued to persist at and around the incision site.Additional interventions at that time included a local anesthetic and steroid injection.A possible route cause of the pain was identified as a small neuroma at the incision site, but was not confirmed.The patient was prescribed oral pain medications on (b)(6) 2021 due to continued pain.On (b)(6) 2021, it was reported to neuropace that the patient underwent explant of the lead located in the area of the pain on (b)(6) 2021.A previously implanted but non-connected lead was then connected to the rns neurostimulator.A biopsy was performed at the time of surgery, which confirmed the presence of a neuroma in the area of pain.The neuroma was removed during the june procedure and the pain was resolved completely.The neuroma was not identified as a pre-existing condition but is believed to be related to the surgical procedure to implant the rns system.

• 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: 12232792
• Report Number: 3004426659-2021-00038
• Device Sequence Number: 17084026
• Product Code: PFN
• UDI-Device Identifier: 00855547005045
• UDI-Public: 010085554700504517220912
• 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: 2020
• 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): 07/23/2021

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: DL-330-10-K
• Device Catalogue Number: 1007605
• Device Lot Number: 28937-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/27/2021
• 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: 41 YR