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 Code	Syncope/Fainting (4411)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 unknown, however it was suspected to be due to an rv lead issue or barostim and possibly both.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) 2024, and on (b)(6) 2025, the patient's therapy was increased from 6.0ma to 7.0ma.Around on (b)(6) 2025, the patient experienced pacemaker inhibition due to rv lead oversensing leading to inhibition of pacing for several seconds.It was noted that the patient experienced syncope during the inhibition episodes.The root cause was unknown, and it was suspected to be due to an rv lead issue or barostim and possibly both.The physician expressed concern regarding the bsx 0184 lead function, and it was noted that impedance was normal on the lead and coils.On (b)(6) 2026, interaction testing was completed for the pacemaker and barostim.Testing revealed pacemaker inhibition after increasing barostim output from 7.0ma to 15.0ma.Barostim output was reduced to 6.0ma, and the rv sensitivity was adjusted from 1.0mv to.50mv and the issue resolved.It was suspected that the crtd device was previously reprogrammed due to pacemaker inhibition.A complete file of programming was requested however, was not received.
Event or Problem Description
A barostim system was implanted on (b)(6) 2024, and on (b)(6) 2025, the patient's therapy was increased from 6.0ma to 7.0ma.Around (b)(6) 2025, the patient experienced pacemaker inhibition due to rv lead oversensing leading to inhibition of pacing for several seconds.It was noted that the patient experienced syncope during the inhibition episodes.The root cause was unknown, and it was suspected to be due to an rv lead issue or barostim and possibly both.The physician expressed concern regarding the bsx 0184 lead function and it was noted that impedance was normal on the lead and coils.On (b)(6) 2026, interaction testing was completed for the pacemaker and barostim.Testing revealed pacemaker inhibition after increasing barostim output from 7.0ma to 15.0ma.Barostim output was reduced to 6.0ma, and the rv sensitivity was adjusted from 1.0mv to.50mv and the issue resolved.It was suspected that the crtd device was previously reprogrammed due to pacemaker inhibition.A complete file of programming was requested and received on (b)(6) 2026.The file was reviewed and looked unremarkable.
Additional Manufacturer Narrative
Updated fileds: b4, b5, g3, g6, h2, h11.Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO2
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRX, INC; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: vincent mbibi ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 24654516
• Report Number: 3007972010-2026-00031
• Device Sequence Number: 12265222
• Product Code: DSR
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 12/08/2025
• Device Model Number: 2104
• Device Catalogue Number: 100065-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• 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: 79 YR
• Patient Sex: Male
• Patient Race: White