MAUDE Adverse Event Report: CVRx, Inc Barostim Neo2; Implantable Pulse Generator

Model Number	2104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Fluid Discharge (2686)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2026.Approximately one day after implant while still in inpatient care, a hematoma was observed at the ipg site and drainage was required.Approximately three days after the patient was discharged it was observed that the neck incision had not scabbed and continued to have drainage and oozing.The patient was admitted to the hospital for approximately five to six days and treated with oral and iv antibiotics.Culture were taken on (b)(6) 2026 and results were negative.There were no known factors that caused or contributed to the event.It was confirmed the patient withheld anticoagulants prior to the procedure per standard of care and restarted after discharge.Per the physician the event was considered known potential complications associated with the surgical procedure.As of (b)(6) 2026 the patient was doing well and the hematoma and neck incision complications had fully resolved.
Additional Manufacturer Narrative
Csl device information: serial number (b)(6), model number 1036, part number 100063-212, manufacture date 2024-09-04, exp date 2026-09-04, udi (b)(4).While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the event was considered known potential complications associated with the surgical procedure.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).

• Brand Name: Barostim Neo2
• Common Device Name: Implantable Pulse Generator
• 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: curtis christian ; 9201west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 50616198
• Report Number: 3007972010-2026-00106
• Device Sequence Number: 10697356
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)260715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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
• Device Expiration Date: 07/15/2026
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Carotid Sinus Lead Serial# (b)(6)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White