BEUDAMED
    FDA Recall Open, Classified

    A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

    Recall: Z-1506-2025 · Initiated January 9, 2025

    Recall

    Recall Number
    Z-1506-2025
    Event Number
    96237
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 9, 2025
    Posted
    April 1, 2025
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

    Reason

    Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

    Action

    Medtronic issued an URGENT: MEDICAL DEVICE correction notice to its consignees on 02/28/2025 via email or US mail. The notice explained the issue and provided recommendations to temporarily mitigate the problem, and requested the following: Actions " Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. " Please provide a copy of the attached patient letter to your affected patients. " Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to [email protected]. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.

    Quantity

    4365 units