MAUDE Adverse Event Report: CVRX, INC BAROSTIM NEO2; IMPLANTABLE PULSE GENERATOR

Model Number	2104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, the root cause of the event was not stated by the physician.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) 2023.Around (b)(6) 2026, the patient was hospitalized due to low blood pressure.The patient believed that their low blood pressure was being caused by barostim.It was noted that the patient had not seen by their physician since moving to a nursing home and the nursing home was in charge of their care and unfamiliar with barostim.It was also noted that the patient was due for a battery change which was scheduled for (b)(6) 2026.
Additional Manufacturer Narrative
Updated fileds: b4, b5, g3, g6, h2, h6, h11.Cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2023.Around (b)(6) 2026, the patient was hospitalized due to low blood pressure.The patient believed that their low blood pressure was being caused by barostim.It was noted that the patient had not seen by their physician since moving to a nursing home and the nursing home was in charge of their care and unfamiliar with barostim.It was also noted that the patient was due for a battery change which was scheduled for (b)(6) 2026.As of (b)(6) 2026, the patient had not had their battery change and was admitted to the hospital for respiratory failure.It was noted that the patient was non-compliant with their medication and medical care and per the surgeon the patient was being evaluated for hospice.

• Brand Name: BAROSTIM NEO2
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• 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: 24605076
• Report Number: 3007972010-2026-00027
• Device Sequence Number: 13349893
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)250227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 02/27/2025
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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: Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male