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

Model Number	1036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nerve Damage (1979); Excessive Tear Production (2235); Numbness (2415); Swelling/ Edema (4577)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2026.Following the procedure, the patient experienced numbness and a swollen tongue and on (b)(6) 2026, the patient presented to the emergency department.A stroke was ruled out at the ed, and the patient was sent home.On (b)(6) 2026 at a scheduled titration follow-up, the patient reported that they experienced a swollen tongue, tongue deviation, difficulty swallowing and speaking, right leg spasms, intermittent headaches, pins and needles sensation on the right side of their face and neck, numbness on the right side of their face and neck, a teary right eye and blurry vision in their right eye.Per the opinion of the physician, the root cause of the tongue movement issues was likely caused by barostim due to the proximity of the hypoglossal nerve, however, was unsure if the other issues were being caused or contributed to by barostim.The physician observed a hard lump under the incision, at the site of the electrode and hypothesized that it might be causing pressure on other surrounding nerves to create these other extraneous complaints.The patient's barostim therapy was turned off to allow more time for healing, and it was noted that there were no changes to the symptoms with therapy off.They were scheduled to have a ct scan in two weeks.As of (b)(6) 2026, the ct scan reading was not yet available.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the tongue movement issues was likely caused by barostim due to the proximity of the hypoglossal nerve, however, was unsure if the other issues were being caused or contributed to by barostim.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).

• Brand Name: BAROSTIM NEO2
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC; 9201west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: vincent mbibi ; 9201west broadway avenue; suite 650; minneapolis, MN 55445 ; 7634162856
• MDR Report Key: 25218548
• Report Number: 3007972010-2026-00060
• Device Sequence Number: 10073406
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)270205
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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 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: 04/22/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: 49 YR
• Patient Sex: Male
• Patient Race: Black Or African American