BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO

    MDR report key: 13020435 · Received December 16, 2021

    Report

    Report Number
    3007972010-2021-00005
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 16, 2021
    Manufacturer
    CVRX, INC.
    Product Code
    DSR
    UDI-DI
    00859144004265
    PMA / PMN Number
    P180050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THE ANALYSIS RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS, THE SITE REPORTED THAT THE LEAD WAS CUT ACCIDENTALLY BY A PHYSICIAN NOT FAMILIAR WITH THE BAROSTIM SYSTEM. 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 NEO SYSTEM WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD A COMPLICATION UNRELATED TO THE CVRX SYSTEM IN THE PAST WEEK THAT WAS TREATED ON (B)(6) 2021. DURING THE INTERVENTION AT A FACILITY UNFAMILIAR WITH BAROSTIM THERAPY, THE POCKET WAS OPENED, AND THE LEAD WAS ACCIDENTALLY CUT. ON (B)(6) 2021, THE LEAD WAS REPLACED. THE DEVICE WAS ACTIVATED WITH A GOOD OUTCOME ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917828 BAROSTIM NEO CAROTID SINUS LEAD DSR CVRX, INC. 1036 00859144004265

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention