BEUDAMED
    FDA Recall Open, Classified

    Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.

    Recall: Z-1574-2022 · Initiated July 26, 2022

    Recall

    Recall Number
    Z-1574-2022
    Event Number
    90685
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 26, 2022
    Posted
    August 25, 2022
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.

    Reason

    Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.

    Action

    On about 07/26/2022, Medtronic notified consignees via letter titled "URGENT: MEDICAL DEVICE CORRECTION" sent through courier service. The notification instructed consignees to hold off implanting more than one Vanta INS in a patient until software update is available and while not recommended, if implanting a patient with two (2) Vanta INSs, ensure the INSs are implanted on opposite sides of the body as noted in the Information for Prescribers labeling, and ensure each is configured with the CP App before implanting in a patient. Consignees were asked to complete and return the customer confirmation form provided an contact Medtronic Technical Services at 1-800-707-0933 if troubleshooting does not resolve any issues encountered.

    Distribution

    Worldwide distribution - US distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. The countries of Austria, Belgium, Canada, Canary Islands, Cayman Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

    Quantity

    4386 downloaded software applications