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

Model Number	2102
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	09/01/2024
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 device interaction.Per the opinion of cvrx's external physician consultant, this event was physician driven, and not related to the device itself, as the interaction was known and device warnings not followed.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 patient with an existing s-icd had a barostim system implanted on (b)(6) 2022 with interaction observed at 8.0ma.The physician was aware that there was a contraindication per the s-icd ifu for the barostim device, but the physician decided to implant barostim anyways.Barostim therapy had been programmed at 6.0ma since on (b)(6) 2023, but no interaction testing was performed at that time.In 2024, during routine hemodialysis, the patient experienced ventricular fibrillation (vf) arrest that the s-icd failed to detect.Cardiopulmonary resuscitation and external defibrillation occurred, and spontaneous circulation was achieved.Electrograms showed high-frequency artifacts synchronous with barostim therapy which resulted in the vf being read as atrial fibrillation.On (b)(6) 2024, barostim therapy was decreased to 1ma and s-icd reprogramming occurred.It was noted the patient had no lasting effects from the event and had recovered.Three months later, the patient experienced ventricular tachycardia, which was detected by the s-icd and appropriately shocked.

• 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: 24861163
• Report Number: 3007972010-2026-00040
• Device Sequence Number: 18459345
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)240314
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 03/14/2024
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2022
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: Black Or African American