BEUDAMED
    FDA Recall Terminated

    VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2

    Recall: Z-2572-2018 · Initiated January 24, 2018

    Recall

    Recall Number
    Z-2572-2018
    Event Number
    80424
    Firm
    LivaNova USA Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    January 24, 2018
    Terminated
    November 29, 2023
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2

    Reason

    Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.

    Action

    Consignees were notified on about 01/24/2018 via URGENT: MEDICAL DEVICE CORRECTION letter. Instructions for physicians with new devices (interrogated for the first time) include to 1) apply the changes and proceed with programming as usual. The warning message requires a mandatory action to Apply Changes. After applying changes, therapy will automatically be programmed to 0 mA. The device may be immediately programmed back on to re-enable therapy. 2) To complete and return the attached Customer Response Form (by fax to (281) 853-1248 or by email to [email protected]. Instructions to physicians with devices that have been implanted (previously interrogated) include 1) Restore the normal and magnet mode stimulation parameters from the Summary screen immediately after the warning message screen. If desired, additional programming changes may be made. 2) For AutoStim (M106 only), detection must be re-enabled first, prior to re-enabling AutoStim therapy. The previous AutoStim parameters are not retained and must be reentered manually. If needed, the previous parameters may be found by ending the session and viewing the Session Report for the generator. 3) Please complete and return the attached Customer Response Form by fax to (281) 853-1248 or by email to [email protected]. Additionally customers were instructed to ensure that this notice is communicated to all relevant personnel within the organization. For questions regarding the information in the letter, please contact Clinical Technical Support at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at [email protected].

    Distribution

    Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.

    Quantity

    243 devices total