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 Purulent Discharge (1812); Unspecified Infection (1930); Skin Discoloration (2074)

Event Date 12/13/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient reported purulent discharge and discoloration in the area near the device.The rns neurostimulator and leads (two cortical strip leads and a depth lead) were explanted on (b)(6) 2021.No additional information was provided by the treating center.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

On (b)(6) 2021, the patient reported purulent discharge and discoloration in the area near the device.The rns neurostimulator and leads (two cortical strip leads and a depth lead) were explanted on (b)(6) 2021.No additional information was provided by the treating center.

Manufacturer Narrative

(b)(4).The explanted product was not returned to neuropace for analysis.Sn should be (b)(6).

Event Description

This is a correction to the device serial number.During an internal audit it was identified that the rns serial number was incorrectly reported.

• 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: 13082387
• MDR Text Key: 285186366
• Report Number: 3004426659-2021-00060
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005366
• UDI-Public: 010085554700536617210824
• 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,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007927
• Device Lot Number: 30525-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• 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
• Patient Age: 53 YR
• Patient Sex: Male