BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO2

    MDR report key: 22133433 · Received June 3, 2025

    Report

    Report Number
    3007972010-2025-00050
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 1, 2025
    Report Date
    August 13, 2025
    Manufacturer
    CVRX, INC
    Product Code
    DSR
    UDI-DI
    00859144004463
    PMA / PMN Number
    P180050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE ANALYSIS WAS UNABLE TO BE PERFORMED AS THE DEVICE WAS NOT RETURNED, PER THE OPINION OF THE PHYSICIAN, THERE WAS AN ADEQUATE AMOUNT OF EXCESS LEAD AND THERE WAS NO REASON FOR TIGHTNESS. 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. FC-(B)(4)

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6, H11. CVRX ID# (B)(4).

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2025 AND LAST TITRATED ON (B)(6) 2025. FOLLOWING THE TITRATION, IT WAS NOTED BY THE PHYSICIAN THAT THE PATIENT HAD VISIBLE LEAD TIGHTNESS AND ON (B)(6) 2025, A LEAD REVISION WAS DONE. WHEN THE PHYSICIAN OPENED THE OPENED THE NECK INCISION IT WAS OBSERVED THAT THERE WAS AN ADEQUATE AMOUNT OF EXCESS LEAD AND THERE WAS NO REASON FOR TIGHTNESS. NO ADJUSTMENT WAS MADE, AND THE LEAD IMPEDANCE WAS GOOD THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851005 BAROSTIM NEO2 CAROTID SINUS LEAD DSR CVRX, INC 1036 00859144004463

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other