MAUDE Adverse Event Report: CVRx, Inc Barostim Neo2; Carotid Sinus Lead

Model Number	1036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Skin Discoloration (2074)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2026.Around (b)(6) 2026, the patient experienced redness and irritation at the neck incision and was hospitalized with a potential infection.Cultures were taken and there was one positive culture from the neck incision for staphylococcus aureus.The physician was not convinced that it was a device infection and as of (b)(6) 2026, the patient remained hospitalized due to chronic chest pains associated with anxiety.On (b)(6) 2026, the surgeon reported that there was no infection and staphylococcus aureus was a common false positive as it is found on human skin and the patient was discharged.It was noted that antibiotics were proactively prescribed before it was confirmed by the physician that there was no device related infection.
Additional Manufacturer Narrative
Updated fileds: b4, b5, g3, g6, h2, h11 cvrx id# (b)(4).

• Brand Name: Barostim Neo2
• Common Device Name: Carotid Sinus Lead
• 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 ; +1(763)416-2856
• MDR Report Key: 50213807
• Report Number: 3007972010-2026-00093
• Device Sequence Number: 6098553
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)280305
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/11/2026

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 Model Number: 1036
• Device Catalogue Number: 100063-212
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2026
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male