BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO2

    MDR report key: 20130339 · Received September 3, 2024

    Report

    Report Number
    3007972010-2024-00051
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    April 1, 2024
    Report Date
    November 27, 2024
    Manufacturer
    CVRX, INC
    Product Code
    DSR
    UDI-DI
    00859144004623
    PMA / PMN Number
    P180050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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, THE ROOT CAUSE OF THE EVENT WAS WAS POOR PATIENT HYGIENE AND WOUND CARE. 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. CVRX ID (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, G3, G6, H2, H11 CVRX ID#(B)(4).

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2024. IN APRIL, THE PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THEIR IPG POCKET. ORAL ANTIBIOTICS WAS PRESCRIBED WHICH IMPROVED BUT DID NOT RESOLVE THE INFECTION. THE PATIENT WAS EVALUATED ON (B)(6) 2024 AND THEY WERE SCHEDULED FOR A POCKET REVISION. THE PATIENT BEGAN TO EXPERIENCE DARK DISCOLORATION AROUND THE POCKET WHICH WAS ATTRIBUTED TO AN INFECTION. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE INFECTION WAS POOR PATIENT HYGIENE AND WOUND CARE. ON (B)(6) 2024 A POCKET REVISION WAS DONE AND THE IPG WAS EXPLANTED. ORAL ANTIBIOTICS WAS PRESCRIBED, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2024. IN APRIL, THE PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THEIR IPG POCKET. ORAL ANTIBIOTICS WAS PRESCRIBED WHICH IMPROVED BUT DID NOT RESOLVE THE INFECTION. THE PATIENT WAS EVALUATED ON (B)(6) 2024 AND THEY WERE SCHEDULED FOR A POCKET REVISION. THE PATIENT BEGAN TO EXPERIENCE DARK DISCOLORATION AROUND THE POCKET WHICH WAS ATTRIBUTED TO AN INFECTION. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE INFECTION WAS POOR PATIENT HYGIENE AND WOUND CARE. ON (B)(6) 2024 A POCKET REVISION WAS DONE AND THE IPG WAS EXPLANTED. ORAL ANTIBIOTICS WAS PRESCRIBED, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. IT WAS REPORTED THAT THE REMOVAL OF THE IPG AND THE ANTIBIOTICS DID NOT RESOLVE THE INFECTION. THERE WAS A PLAN TO EXPLORE REMOVAL OF THE REMAINING LEAD. AS OF (B)(6) 2024, THE PATIENT DID NOT RETURN, AND IT WAS ASSUMED THAT THE SYMPTOMS WAS IMPROVING AND NO ADDITIONAL INTERVENTION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277250 BAROSTIM NEO2 IMPLANTABLE PULSE GENERATOR DSR CVRX, INC 2104 00859144004623

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H