MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; IMPLANTABLE PULSE GENERATOR

Model Number	2102
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Chest Pain (1776); Swelling/ Edema (4577); Restless Legs Syndrome (4584); Facial Paralysis (4585)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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) 2022.On 2(b)(6) 2025, the patient was in the cardiac care unit for chest pain, and the patient alleged it was related to barostim.The patient also experienced increased edema in their left extremities, and a right heart catheterization was planned.The patient also reported they experienced some facial droop and restless leg syndrome (rls) since approximately (b)(6) 2025 related to barostim, and the symptoms had subsided when a magnet was placed on barostim.The patient also alleged part of the barostim had migrated to their groin shortly after implant; however, they never reported this allegation to any physician, no x-ray was ever performed, titrations had occurred without issue, and no lead impedance issues were noted.It was noted that barostim had last been interrogated in (b)(6) 2023 with an anticipated battery life through (b)(6) 2026.Barostim therapy was turned off, it was planned to manage the patient's medications and diuretics for the edema, and the patient no longer had a managing cardiac physician.

• Brand Name: BAROSTIM NEO
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 22544180
• Report Number: 3007972010-2025-00064
• Device Sequence Number: 12567177
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)231215
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/15/2023
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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: Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: White