BEUDAMED
    FDA Recall Open, Classified

    Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

    Recall: Z-1543-2025 · Initiated March 4, 2025

    Recall

    Recall Number
    Z-1543-2025
    Event Number
    96445
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 4, 2025
    Posted
    April 8, 2025
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

    Reason

    There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

    Action

    An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated March 2025 was sent to customers. The letter described the product, problem and actions to be taken. Required Actions: When utilizing any of the lead options mentioned above, avoid using the Switch Device feature to transfer data from the Model A71300 Stimulation Trialing CP App to the Model A71400 Stimulation RC CP App. As an alternative, manually enter the patient and lead information using the Model A71400 Stimulation RC CP App, ensuring not to utilize the Switch Device feature. Inform relevant medical staff about the potential of this issue and the steps to mitigate it. Ensure that backup INS devices are readily available for scheduled surgeries. During the implant procedure, check the system integrity before securing the neurostimulator in place as described in the Inceptiv/Intellis Pro Implant Manual. Please complete and return the customer confirmation form enclosed in this letter acknowledging that you have received this information. Please contact Medtronic Technical Services at 1-800-707-0933 if you have any questions regarding this communication.

    Distribution

    Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

    Quantity

    1493 devices