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

Model Number	1036
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Serious Injury
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 event was that the csl migrated into subcutaneous muscle however, per the x-ray's, it appears that the electrode separated from the lead body as a result of the chiropractic adjustment.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.Id#: (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2024.The patient was seen for a device interrogation on (b)(6) 2026, and it was discovered that around on (b)(6) 2025 the system was out of compliance and the lead impedance was high.It was noted that the patient had a chiropractic adjustment that corresponded with the date of the impedance change.An x-ray was ordered and the patient's therapy was deactivated.Per the opinion of the physician, the root cause of the event was that the csl migrated into subcutaneous muscle however, per the x-ray's, it looked like the electrode was separating from the lead body.They were scheduled for a follow-up on (b)(6) 2026, however as of on (b)(6) 2026, there were no additional updates provided.It was noted that the surgeon's office was going through a transition and was unresponsive on all issues.On (b)(6) 2026, the patient's device was explanted successfully and sent to pathology.An attempt was made to retrieve the explanted device but was unsuccessful.

• 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 ; 7634162856
• MDR Report Key: 25306819
• Report Number: 3007972010-2026-00065
• Device Sequence Number: 13140936
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)250517
• 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: 2024
• 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): 05/27/2026

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: 05/17/2025
• Device Model Number: 1036
• Device Catalogue Number: 100066-102
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Race: White