BAROSTIM NEO2
Received Jul 17, 2026 · Event occurred Jun 7, 2026
Report 3007972010-2026-00085 · MDR key 25855076
Device
Product problems
- Use of Device Problem
Patient
79 YR · Male
- Hematoma
Narrative
Description of Event or Problem
A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT FELL FORWARD ON THEIR BED, CAUSING A HEMATOMA ON THEIR CHEST AND IPG POCKET. THEY WERE TAKEN TO THE HOSPITAL BECAUSE OF THE BRUISE. ON (B)(6) 2026, THE POCKET WAS REOPENED AND THE HEMATOMA WAS EVACUATED. AS OF(B)(6) 2026, THERE WERE NO FURTHER COMPLAINTS FROM THE PATIENT.
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 PATIENT FALLING FORWARD ON THEIR BED. 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).