BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO

    MDR report key: 14705713 · Received June 15, 2022

    Report

    Report Number
    3007972010-2022-00009
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    April 30, 2022
    Report Date
    June 15, 2022
    Manufacturer
    CVRX, INC.
    Product Code
    DSR
    UDI-DI
    00859144004432
    PMA / PMN Number
    P180050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED FROM THE SITE, THE HICCUP-INDUCED VOMITING AND SYNCOPE WAS PROCEDURALLY RELATED TO THE HIGH BIFURCATION OF THE PATIENT'S ANATOMY. THE OPINION OF THE PHYSICIAN WAS THAT THE EVENT WAS NOT RELATED TO THE DEVICE. THE DEVICE HISTORY AND STERILIZATION RECORDS 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. (B)(4).

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THERAPY WAS LEFT ACTIVATED AT 125/1/40. ON (B)(6) 2022 THE PATIENT EXPERIENCED A SYNCOPAL EPISODE DUE TO HICCUP INDUCED VOMITING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022. NO DEVICE INTERVENTION WAS PERFORMED, AND THE PATIENT WAS MANAGED WITH MEDICATIONS. THE PATIENT WAS FULLY RECOVERED AND DISCHARGED HOME ON (B)(6) 2022. IN THE OPINION OF THE PHYSICIAN, THE HICCUP-INDUCED VOMITING AND SYNCOPE WAS PROCEDURALLY RELATED TO THE HIGH BIFURCATION OF THE PATIENT'S ANATOMY AND WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254217 BAROSTIM NEO CAROTID SINUS LEAD DSR CVRX, INC. 2102 00859144004432

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization