BEUDAMED
    FDA Recall Open, Classified

    Model A710 Intellis Clinician Programmer Application, version 2.0.97

    Recall: Z-0780-2024 · Initiated December 19, 2023

    Recall

    Recall Number
    Z-0780-2024
    Event Number
    93714
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 19, 2023
    Posted
    January 22, 2024
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Model A710 Intellis Clinician Programmer Application, version 2.0.97

    Reason

    Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

    Action

    OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.

    Distribution

    Germany

    Quantity

    1 tablet