BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO2

    MDR report key: 25191642 · Received May 15, 2026

    Report

    Report Number
    3007972010-2026-00058
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 15, 2026
    Manufacturer
    CVRX, INC.
    Product Code
    DSR
    UDI-DI
    00859144004623
    PMA / PMN Number
    P180050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AT THIS TIME, AND THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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# FC-(B)(4).

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. IT WAS NOTED THERE WERE BRIEF PERIODS OF BRADYCARDIA DURING IMPLANT THAT WERE NOT OF CONCERN TO THE SURGEON OR ANESTHESIOLOGIST. LATER THAT DAY, THE PATIENT HAD EXPERIENCED A CODE BLUE AND WAS UNRESPONSIVE. AN MRI WAS PLANNED. IT WAS NOTED THE PATIENT WOKE APPROXIMATELY FIVE DAYS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132757 BAROSTIM NEO2 IMPLANTABLE PULSE GENERATOR DSR CVRX, INC. 2104 00859144004623

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other