MAUDE Adverse Event Report: CVRX, INC BAROSTIM NEO2; CAROTID SINUS LEAD

Model Number	1036
Medical Device Problem Codes	Material Twisted/Bent (2981); Unintended Movement (3026)
Health Effect - Clinical Codes	Fatigue (1849); Undesired Nerve Stimulation (1980); Twiddlers Syndrome (4563)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id#: (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.Around on (b)(6) 2026, the patient's lead impedance decreased rapidly.It was noted that around that time, the device turned while the patient was waking up and the patient manually turned it back.The device was tested and constantly passed compliance and stim was experienced once.Therapy was still being delivered, however the patient reported being more tired in a timeframe that coincides with the impedance drop.An x-ray was ordered and the images revealed that the ipg dropped inferior to the chest wall, as well as multiple coils in the lead near the header of the ipg.A lead revision occurred on (b)(6) 2026.The damaged lead and the ipg were explanted and a new generator and lead were implanted.

• 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
• MDR Report Key: 24991398
• Report Number: 3007972010-2026-00047
• Device Sequence Number: 15849951
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)260723
• 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: 2025
• Device Explanted 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): 04/25/2026

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: 07/23/2026
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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: 53 YR
• Patient Sex: Female
• Patient Race: Black Or African American