BEUDAMED
    FDA Enforcement Class I Terminated

    VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy

    Recall: Z-0561-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0561-2020
    Event ID
    83873
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    August 22, 2019
    Classification Date
    December 20, 2019
    Termination Date
    March 28, 2024
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069, United States

    Description

    VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy

    Reason

    Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.

    Code Info

    Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen.

    Distribution

    U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT

    Quantity

    1687