BAROSTIM NEO2

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 WEAK FASCIA CONTRIBUTING TO POCKET EXPANSION, WHICH ALLOWED THE PATIENT TO MANIPULATE THEIR DEVICE AND ROTATE IT IN THE POCKET. 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).

Description of Event or Problem

AN IPG REPLACEMENT OCCURRED ON (B)(6) 2026 AND WAS SUTURED TO THE FASCIA WITH TWO SUTURES AFTER BEING PLACED IN AN ANTIBACTERIAL POUCH. THE IPG BECAME LOOSE IN THE POCKET ON (B)(6) 2026 AND WAS ABLE TO BE MANIPULATED UNDER THE SKIN. IT WAS NOTED THE PATIENT DID NOT EXPERIENCE ANY PAIN OR OTHER SYMPTOMS. THE PHYSICIAN SPECULATED THE ROOT CAUSE OF THE MOVEMENT WAS EITHER PATIENT TWIDDLING OR WEAK FASCIA. ON (B)(6) 2026, A POCKET REVISION OCCURRED. IT WAS NOTED THAT THE SUTURES WERE STILL INTACT, BUT WEAK FASCIA CONTRIBUTED TO POCKET EXPANSION, WHICH ALLOWED THE PATIENT TO MANIPULATE THEIR DEVICE AND ROTATE IT IN THE POCKET. THE IPG WAS PLACED SUBMUSCULAR AND PLACED WITHIN A BIOENVELOPE TO HELP WITH POCKET STABILITY. AS OF (B)(6) 2026, NO FURTHER COMPLAINTS HAD BEEN RECEIVED.