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

Model Number	1036
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Neck Pain (2433)
Date of Event	12/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2025 and last titrated on (b)(6) 2025 where therapy amplitude was increased from 6.4ma to 7.0ma.Around (b)(6) 2025, the patient experienced extraneous stimulation in the form of tightness on the right side of their neck which worsened around (b)(6) 2026.The patient was seen for a follow up on (b)(6) 2026 and they were able to replicate the stim by raising their right arm.The patient's therapy was reduced to 5.0ma and the stim resolved.On a later date, the patient continued to experience tightness in their throat.On (b)(6) 2026, the patient's therapy was adjusted to 4.2ma.Labs were ordered as the clinicians believed that the patient's chf may have worsened.The patient continued to experience issues with stim near their throat and imaging was done.The electrode and the positioning of the device looked good, however the excess lead in the pocket appeared to have migrated underneath the bottom of the ipg which potentially caused a pulling like sensation on the lead.Per the opinion of the physician, the root cause of the migration was possibly due to the patient's bariatric surgery which caused a lot of excess skin and potentially caused the lead to slide down under the ipg post op.On (b)(6) 2026, the physician performed a pocket revision to fix the lead.The patient was seen for a follow up on (b)(6) 2026 and it was noted that was feeling well.On (b)(6) 2026, tightness in the neck occurred and the pulse width was adjusted back to 125.The patient was seen for a follow up on (b)(6) 2026 and stated that they were feeling good.The patient was seen for a follow up on (b)(6) 2026 and reported that they continued to experience persistent throat tightness and required head position adjustment to breathe, along with a sensation of electrical current radiating up their neck and down their throat.It was noted that the sensation remained present when therapy was on or off and was possibly related to the device positioning.There was no significant impedance change noted and the patient's therapy was disabled.
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 migration was possibly due to the patient's bariatric surgery which caused a lot of excess skin and potentially caused the lead to slide down under the ipg post op.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: 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: 50753367
• Report Number: 3007972010-2026-00107
• Device Sequence Number: 9550389
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)251102
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 11/02/2025
• 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: 03/11/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: White