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	10/19/2025
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 there was a connection issue between the lead and the header.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) 2025 and the patient lead impedance was 1300.On (b)(6) 2025, the patient's lead impedance was 3900 and as of (b)(6) 2025, remained stable.It was suspected that there was an issue with the connection between the lead pin and set pin in the header of the ipg and the root cause of the event was being further investigated.The patient was seen for a follow up on 10-dec-2025 and it was noted that the impedance was still high and the device was not in compliance.An x-ray revealed and confirmed the connection issue between the lead and the header as the lead pin was not visible past the distal block in the header.A lead revision occurred on (b)(6) 2026 and the impedance issue resolved.The patient was seen for a follow up on 27-jan-2026 and it was confirmed that the lead impedance trend returned to normal since the revision.

• Brand Name: BAROSTIM NEO2
• Common Device Name: CAROTID SINUS LEAD
• 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: 24324524
• Report Number: 3007972010-2026-00015
• Device Sequence Number: 15944227
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)261211
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/12/2026

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: 01/15/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Race: White