BEUDAMED
    FDA Recall Open, Classified

    Percept BrainSense Implantable Neurostimulator (INS), Model B35200

    Recall: Z-1128-2022 · Initiated March 30, 2022

    Recall

    Recall Number
    Z-1128-2022
    Event Number
    89994
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 30, 2022
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Percept BrainSense Implantable Neurostimulator (INS), Model B35200

    Reason

    The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

    Action

    A customer letter, dated March 2022, was issued to the impacted consignee via mail. The consignee is instructed to ensure the patient programmer system is set up to communicate with the patient's INS at the patient's initial programming session. If a patient's INS cannot communicate with the clinician programmer and/or patient programmer system, and it is not possible to make therapy adjustments or turn stimulation off, the consignee should contact Medtronic Technical Services at 1-800-707-0933. The consignee is also asked to complete the customer confirmation form and submit to the recalling firm.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.

    Quantity

    14164 units