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

Model Number RNS-320-K

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

Patient Problems Wound Dehiscence (1154); Erosion (1750); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 12/20/2022

Event Type  Injury  

Event Description

The patient was implanted on (b)(6) 2022.A postop visit on (b)(6) 2022 demonstrated a well healed incision.The patient was evaluated by the doctor on (b)(6) 2022, wound dehiscence was noted and the patient was started on antibiotics.The wound was checked 1 week later and the antibiotics were extended.On (b)(6) 2022, the patient was brought to emergency department with wound drainage.The patient underwent wound debridement and closure on (b)(6) 2022.On (b)(6) 2022, the patient had a revision of the wound with skin graft and revision of rns device.The patient developed a recurrent hardware exposure reported on (b)(6) 2022.The patient then had the rns system explanted (neurostimulator and two leads) on (b)(6) 2022.The patient had tissue expanders placed on (b)(6) 2024.This was diagnosed as a deep and superficial infection, dehiscence, erosion, impaired healing, infection were reported.Keflex (10 days), doxycycline (7 days), vancomycin/ceftriaxone (6 weeks), duricef (28 days).

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.

• 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 ; 5108822607
• MDR Report Key: 18896075
• MDR Text Key: 337575064
• Report Number: 3004426659-2024-00018
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617221027
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1008191
• Device Lot Number: 32220-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female