BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO

    MDR report key: 14305602 · Received May 6, 2022

    Report

    Report Number
    3007972010-2022-00006
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 5, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN RECEIVED. THE DEVICE HISTORY RECORD 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 AS WELL AS STERILIZATION REQUIREMENTS. CVRX ID# (B)(4).

    Additional Manufacturer Narrative · 0

    CVRX ID: (B)(4).

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THE PATIENT DEVELOPED SYMPTOMS OF AN INFECTION, INCLUDING SWELLING AT THE NECK INCISION, AND WAS HOSPITALIZED ON (B)(6) 2022. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS FROM (B)(6) 2022 THROUGH (B)(6) 2022. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 ON ORAL ANTIBIOTICS, AND AN EXPLANT WAS SCHEDULED FOR (B)(6) 2022. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2022 IN PREPARATION FOR THE EXPLANT ON (B)(6) 2022. DURING THE PROCEDURE, THE POCKET WAS WASHED OUT, AND A CULTURE TAKEN. THE BAROSTIM SYSTEM WAS NOT EXPLANTED. THE PATIENT REMAINED HOSPITALIZED ON ANTIBIOTICS. CULTURE RESULTS CAME BACK AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA), AND A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE SYSTEM. AS OF (B)(6) 2022, THE PATIENT REMAINED HOSPITALIZED AND ON ANTIBIOTICS.

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THE PATIENT DEVELOPED SYMPTOMS OF AN INFECTION, INCLUDING SWELLING AT THE NECK INCISION, AND WAS HOSPITALIZED ON (B)(6) 2022. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS FROM (B)(6) 2022 THROUGH (B)(6) 2022. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 ON ORAL ANTIBIOTICS, AND AN EXPLANT WAS SCHEDULED FOR (B)(6) 2022. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2022 IN PREPARATION FOR THE EXPLANT ON (B)(6) 2022. DURING THE PROCEDURE, THE POCKET WAS WASHED OUT, AND A CULTURE TAKEN. THE BAROSTIM SYSTEM WAS NOT EXPLANTED. THE PATIENT REMAINED HOSPITALIZED ON ANTIBIOTICS. CULTURE RESULTS CAME BACK AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA), AND A PROCEDURE WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE SYSTEM, AND THE PATIENT REMAINED ON ORAL ANTIBIOTICS POST EXPLANT. AS OF (B)(6) 2022, THE PATIENT HAD BEEN RELEASED FROM THE HOSPITAL, BUT THE SITE DECLINED TO PROVIDE INFORMATION ON IF THE INFECTION CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214289 BAROSTIM NEO CAROTID SINUS LEAD DSR CVRX, INC. 2102 00859144004432

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H