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

Model Number RNS 320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.

Event Description

During the patient's follow up visit on (b)(6) 2022, her treating team observed part of the incision line scab presented as slightly wide / deep.There was no obvious outward sign of infection (i.E.Pus), only typical wound weeping.On (b)(6) 2022 the patient underwent a superficial wound washout and cultures.Post-surgical outcome, no signs of infection.Diagnosed as a minor incisional dehiscence.Wound wash was performed and the incision site reclosed.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 6502382788
• MDR Report Key: 15286965
• MDR Text Key: 298563086
• Report Number: 3004426659-2022-00027
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617221208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS 320
• Device Catalogue Number: 1008191
• Device Lot Number: 32151-1-1-1
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 15 YR
• Patient Sex: Female