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 Code	Swelling/ Edema (4577)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.Following implant, the patient experienced difficulty swallowing and swelling at the neck incision.The certified physician assistant ruled out an infection as the patient's white blood cell count was not elevated.A ct was performed and revealed fluid and gas collection along the left neck stimulator lead and anterior to left carotid space.Per the opinion of the physician, based on the imaging results the root cause of the event was related to abscess.The patient was put on antibiotics, and an aspiration of the abscess was performed.The patient was seen for a follow up on 19-dec-2025 and it was confirmed that they were doing well.The patient reported that they were hospitalized for a high fever and confusion on (b)(6) 2025.The patient was seen for a follow up on 16-jan-2026 and they reported that the difficulty swallowing and difficulty of pressing their lips together resolved and the swelling was reduced.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, per the opinion of the physician, based on the imaging results the root cause of the event was related to an abscess.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.Following implant, the patient experienced difficulty swallowing and swelling at the neck incision.The certified physician assistant ruled out an infection as the patient's white blood cell count was not elevated.A ct was performed and revealed fluid and gas collection along the left neck stimulator lead and anterior to left carotid space.Per the opinion of the physician, based on the imaging results the root cause of the event was related to abscess.The patient was put on antibiotics, and an aspiration of the abscess was performed.The patient was seen for a follow up on (b)(6) 2025 and it was confirmed that they were doing well.The patient reported that they were hospitalized for a high fever and confusion on (b)(6) 2025 unrelated to barostim.The patient was seen for a follow up on (b)(6) 2026 and they reported that the difficulty swallowing and difficulty of pressing their lips together resolved and the swelling was reduced.As of (b)(6) 2026, it was confirmed that the patient was doing well.
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; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRX, INC; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 24326559
• Report Number: 3007972010-2026-00016
• Device Sequence Number: 15964952
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)261105
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 01/16/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Race: White