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

Model Number	1036
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2025.On (b)(6) 2026, impedance was low, and barostim therapy was turned off.It was noted the system passed compliance as of the last barostim check on (b)(6) 2026, but the lead impedance had decreased significantly from approximately 850 to 150 ohms on approximately (b)(6) 2026 and decreased to low around (b)(6) 2026.There were no unusual events or physical stresses on the system reported by the patient, and the patient did not report any symptoms or adverse events.A chest and neck x-ray were ordered and showed the lead completely detached from the ipg header.In the opinion of the physician, the root cause of the lead detachment could not be conclusively determined, but twiddler syndrome was possible as the patient reported frequent touching of their ipg pocket.A successful lead revision occurred on 16-jul-2026.The old lead was extracted, and a new lead was placed on the same carotid artery with a good bp response.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, in the opinion of the physician, the root cause of the lead detachment could not be conclusively determined, but twiddler syndrome was possible as the patient reported frequent touching of their ipg pocket.The manufacturer notes that although twiddler's syndrome may have been part of the issue, it is clear that the setscrews of the lead were not properly tightened by the surgeon at the initial implant.Had that been done, ultimately the lead would have broken, not pulled free from the header, as reported.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 ; +1(763)416-2856
• MDR Report Key: 50223996
• Report Number: 3007972010-2026-00094
• Device Sequence Number: 18733284
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)270306
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/12/2026

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: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: 46 YR
• Patient Sex: Female