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

Model Number	2104
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2026 and last titrated from 4.0ma to 7.0ma on (b)(6) 2026.On (b)(6) 2026 the patient experienced itching at the chest pocket.In the early morning of (b)(6) 2026 the patient was shocked by their evicd.The patient saw the icd physician and was discharged.In the evening of (b)(6) 2026 the patient received another shock from their icd and went to the emergency room where the icd was turned off.Barostim was reduced to 4.0ma and the icd was turned back on and the patient was allowed to go home.It was confirmed there were no precipitating factor that led up to the shocks and there were no issues with stimulation.At a titration appointment on (b)(6) 2026 the barostim settings were tested at 4.0ma, 5.0ma, and 6.0ma and no oversensing was observed from the icd.The physician requested the amplitude be left at 5.0ma.Per the physician the icd shocks were due to oversensing of barostim.The patient was reported to be stable and doing well.
Additional Manufacturer Narrative
The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.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 device interaction that resulted in oversensing on the patient's icd and delivered shocks.A review of the icd log showed what appeared to be standard rv oversensing that resulted in vf detection and shocks.The icd sensing of barostim was intermittent, and if the icd detected the interaction within the vt zone the icd appropriately labeled the events as oversensing and did not treat them.However, when the interaction onset was fast enough to reach the vf zone the icd misidentified the oversensing and delivered a shock.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: 50508841
• Report Number: 3007972010-2026-00102
• Device Sequence Number: 18443886
• Product Code: DSR
• UDI-Device Identifier: 00859144004623
• UDI-Public: (01)00859144004623(17)270708
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 07/31/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 200 LB
• Patient Race: Black Or African American