MAUDE Adverse Event Report: CVRx, Inc Barostim Neo2; Implantable Pulse Generator

Model Number	2104
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury

• Brand Name: Barostim Neo2
• Common Device Name: Implantable Pulse Generator
• Manufacturer (Section D): CVRx, Inc; 9201west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRx, Inc; 9201west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: vincent mbibi ; 9201west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 50949201
• Report Number: 3007972010-2026-00114
• Device Sequence Number: 16063865
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)250818
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Lay User/Patient
• Device Expiration Date: 08/18/2025
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: White