BAROSTIM NEO2
Received Jul 22, 2026 · Event occurred Jun 5, 2026
Report 3007972010-2026-00086 · MDR key 25905165
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
82 YR · Female
- Pocket Erosion
Narrative
Description of Event or Problem
A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2019, AND A NORMAL IPG REPLACEMENT OCCURRED ON(B)(6) 2025. AROUND (B)(6) 2026, THE PATIENT EXPERIENCED THEIR IPG PROTRUDING THROUGH THEIR CHEST WALL. THERE WERE NO SIGNS OF INFECTION, AND THE PATIENT IGNORED THE PAIN THEY EXPERIENCED. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS THE PATIENTS WEIGHT LOSS AND THE POSITION OF THE DEVICE WITHIN THE BREAST POCKET. ON (B)(6) 2026, A POCKET REVISION WAS DONE AND THE IPG WAS REPLACED. IT WAS NOTED THAT THE OLD IPG POCKET WAS TREATED AND CLOSED AND A NEW POCKET WAS CREATED.
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 THE PATIENTS WEIGHT LOSS AND THE POSITION OF THE DEVICE WITHIN THE BREAST 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).