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

Model Number	2104
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2025 and last titrated from 6.0 to 7.0ma on (b)(6) 2026.Icd shocks occurred on (b)(6) 2026.Icd adjustments were made on (b)(6) 2026, and the electrophysiologist reported the event was caused or contributed to by barostim.It was noted the patient had a complicated history that included non-ischemic cardiomyopathy, prior vt ablation, prior scd, af/atrial tach, hf, and inoperable bladder diverticulum.It was also reported that the patient was a competitive triathlete, played tennis, and was very active after his hf diagnosis almost 20 years ago.The patient was still biking and swimming vigorously.The patient was seen for a follow up on (b)(6) 2026, and their therapy was reduced from 7.0ma to 1.0ma at the request of the physician.There was a plan to work with the abbott rep, and physician to find a programming where the icd and the barostim can coexist safely.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, the electrophysiologist reported the event was caused or contributed to by barostim.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)(6).

• 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 ; +1(763)416-2856
• MDR Report Key: 50015469
• Report Number: 3007972010-2026-00088
• Device Sequence Number: 16089747
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)270206
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: 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: 06/25/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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: Male