Barostim Neo2

Description of Event or Problem

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).