BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO

    MDR report key: 14577430 · Received June 2, 2022

    Report

    Report Number
    3007972010-2022-00007
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 2, 2022
    Manufacturer
    CVRX, INC.
    Product Code
    DSR
    UDI-DI
    00859144004432
    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 SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY 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).

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THE PATIENT EXPERIENCED A HEMATOMA AT THE POCKET SITE ON 11-MAY-2022 AND WAS ADMITTED TO THE HOSPITAL ON 12-MAY-2022. THE HEMATOMA WAS WASHED OUT, AND THERE WERE NO SIGNS OF INFECTION. THE PATIENT WAS DISCHARGED ON 13-MAY-2022. AT THE FOLLOW-UP APPOINTMENT ON 31-MAY-2022, THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160316 BAROSTIM NEO CAROTID SINUS LEAD DSR CVRX, INC. 2102 00859144004432

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R