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	Undesired Nerve Stimulation (1980); Discomfort (2330)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While analysis of the reported csl 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 the ipg was not implanted deep enough in the chest wall.The device history and sterilization record for this csl device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event, and the device passed all pull testing specifications.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.Following implant, the patient experienced pain at the chest incision site and the ipg was sticking out of their skin and causing discomfort.They also expressed concern with the stimulation they felt when therapy levels were adjusted and stated it felt like they were being electrocuted with every adjustment.The patient was also concerned that their lead did not have the appropriate points of contact on their carotid.It was noted that the impedance levels complied and an ultrasound and ct looked good as well.Per the opinion of their previous physician, the root cause of the event was that the ipg was not implanted deep enough in the chest wall.The patient was seen for a consultation on (b)(6) 2026, to discuss a possible revision, and on (b)(6) 2026, the patient underwent a lead and pocket revision and the ipg was replaced.They reported feeling much better following the revision.They were seen for a follow-up on (b)(6) 2026 with no further complaint, and all the patient's symptoms were resolved.

• 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: vincent mbibi ; 9201west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 24931601
• Report Number: 3007972010-2026-00046
• Device Sequence Number: 10727346
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)260715
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/20/2026

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: 07/15/2026
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: White