BEUDAMED
    FDA Recall Open, Classified

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E

    Recall: Z-0915-2023 · Initiated December 3, 2022

    Recall

    Recall Number
    Z-0915-2023
    Event Number
    91296
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 3, 2022
    Posted
    January 6, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E

    Reason

    Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

    Action

    The firm issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 12/03/2022 by mail. The notices explained the problems and the associated risks and provided the following: "Recommended Mitigation If the INS cannot be interrogated with Vanta PP App, contact Medtronic Technical Services at 1-800-707-0933. If needed, Medtronic will schedule an in-field service appointment with the managing SCS physician and the patient to diagnose and reset the INS." "Medtronic is working on a Vanta CP App software update that will resolve this issue and will communicate additional information when it becomes available."

    Distribution

    Worldwide distribution.

    Quantity

    22 units