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

Model Number	1036
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2024 and last titrated on (b)(6) 2024 where therapy was increased from 7.4ma to 9.0ma.Around (b)(6) 2025, the patient experienced pulling in their neck.The surgeon noted that after palpating the lead, it felt "as tight as a guitar string".Around (b)(6) 2026, the patient had a ct done.The ct of the chest was done in a supine position, and the lead appeared to have slack.Additional imaging was being done, however was not yet available.A suggestion was made to adjust the patient's therapy to rule out stimulation.The surgeon was working with the cardiologist to schedule the patient for a lead revision.It was noted that the patient had a poor prognosis due to cancer diagnosis and chose to have the device explanted and they needed to put a port in as they were undergoing chemo.Per the opinion of the physician, the root cause of the event was possibly due to radiation therapy on the lead.The device was explanted on (b)(6) 2026.
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 possibly due to radiation therapy on the lead.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.H6: medical device problem code 3191: suggested code: tight lead.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 ; 7634162856
• MDR Report Key: 25311580
• Report Number: 3007972010-2026-00067
• Device Sequence Number: 10535463
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)250215
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 02/15/2025
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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: 63 YR
• Patient Sex: Male