BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAROSTIM NEO2

    MDR report key: 19701430 · Received July 9, 2024

    Report

    Report Number
    3007972010-2024-00036
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 11, 2024
    Report Date
    October 28, 2024
    Manufacturer
    CVRX, INC
    Product Code
    DSR
    UDI-DI
    00859144004425
    PMA / PMN Number
    P180050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H3, H6, H11. THE ANALYSIS RESULTS INDICATED A SOFTWARE DEFECT IN THE 1.5 IPG APPLICATION (250039-001B) THAT CAN CAUSE AN UNHANDLED EXCEPTION IF THE TELEMETRY LINK IS LOST DURING A PARTICULAR SOFTWARE STATE TRANSITION. THE SOFTWARE DEFECT CAUSING AN IPG001 UNHANDLED EXCEPTION IS RARE AND IT IS NOT POSSIBLE TO ESTIMATE THE PROBABILITY OF OCCURRENCE OF THIS DEFECT FROM THE CODE ANALYSIS. CVRX ID# (B)(4).

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AT THIS TIME, AND THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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, D9, G3, G6, H2, H11. ANALYSIS OF THE REPORTED DEVICE IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. CVRX ID# (B)(4).

    Description of Event or Problem · 0

    A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2024. DURING THE IMPLANT PROCEDURE, THERE WAS SOME LOSS OF TELEMETRY BETWEEN THE PROGRAMMER AND IPG, BUT THE PATIENT'S INFORMATION WAS ABLE TO BE ENTERED AND THE MAPPING PROCESS WAS STARTED. WHEN THE PHYSICIAN WAS ABOUT TO START TUNNELING THE LEAD AND CREATING A DEVICE POCKET, THE PROGRAMMER LOST TELEMETRY CONNECTION WITH THE IPG AGAIN AND SHOWED "ERROR IPG001". RESTARTING THE PROGRAMMER SOFTWARE DID NOT RESOLVE THE ISSUE IMMEDIATELY, HOWEVER, RESTARTING THE LAPTOP AND SOFTWARE FIXED THE CONNECTION AGAIN. THE PHYSICIAN WAS NOTIFIED OF THE ONGOING ISSUE, BUT SINCE THE DEVICE SEEMED TO BE WORKING FINE AGAIN AND A SUCCESSFUL STIMULATION WAS REPRODUCED, THE SURGEONS CONTINUED TO CLOSE THE IPG POCKET. AS THE LAST CLOSING SUTURE WAS DONE, THE ERROR MESSAGE SHOWED AGAIN. THE NEW OCCURRENCE OF THE ERROR MESSAGE WAS REPORTED TO THE SURGEONS AND AS THERE WAS NO WAY TO CONFIRM THAT THERE WOULD BE NO MALFUNCTION IN THE IPG, A DECISION WAS MADE TO REMOVE THE IPG AND USE A DIFFERENT IPG. THE POCKET WAS OPENED AND THE IPG WAS REMOVED AND REPLACED WITH A NEW ONE. THE POCKET WAS CLOSED AND THERE WAS NO MORE OCCURRENCE OF THE ERROR MESSAGE. THERE WAS NO ADVERSE EVENT EXPERIENCED BY THE PATIENT AND THE PROCEDURE WAS NOT DELAYED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269324 BAROSTIM NEO2 IMPLANTABLE PULSE GENERATOR DSR CVRX, INC 2104 00859144004425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other