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

Model Number	DL-344-10-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The leads were returned to neuropace and investigated.There was evidence that the leads were damaged as a result of the explant procedure.There was no damage associated with the reported infection.The following leads were explanted; sn (b)(4), udi (b)(4).Sn (b)(4), udi (b)(4).
Event or Problem Description
Neuropace was notified that the patient developed an infection at the incision site and subsequently had both depth leads explanted on (b)(6) 2019.The surgical site was washed-out with an antibiotic solution after the leads were removed.Cultures from the procedure are pending.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Culture results provided by 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: 8551031
• Report Number: 3004426659-2019-00013
• Device Sequence Number: 10862956
• Product Code: PFN
• UDI-Device Identifier: 00855547005038
• UDI-Public: 010085554700503817200828
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 05/15/2019

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: DL-344-10-K
• Device Catalogue Number: 1007607
• Device Lot Number: 25991-1-1-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/17/2019
• 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; Other
• Patient Age: 16 YR