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 Bacterial Infection (1735); Skin Erosion (2075)

Event Date 06/29/2022

Event Type  Injury  

Event Description

The patient presented with a skin breakdown at the posterior aspect of the incision site.Diagnosed as a deep incisional infection cultures were positive for gram-positive cocci.On (b)(6) 2022, the patient's neurostimulator and leads were explanted.Treatment included 10-day keflex treatment followed by 6-week course of linazolid and a second course of linozolid for 8 weeks.

Manufacturer Narrative

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

• 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: 15148068
• MDR Text Key: 297069401
• Report Number: 3004426659-2022-00016
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617220406
• 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
• Type of Report: Initial
• Report Date: 07/25/2022

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
• Device Model Number: RNS 320
• Device Catalogue Number: 1007927
• Device Lot Number: 31243-1-1-1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 08/02/2022
• 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): Other; Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male