BEUDAMED
    FDA Enforcement Class II Terminated

    VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    Recall: Z-0555-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0555-2018
    Event ID
    78914
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cyberonics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    February 14, 2018
    Initiation Date
    December 2, 2017
    Classification Date
    February 8, 2018
    Termination Date
    August 6, 2018
    Address
    100 Cyberonics Blvd, N/A, Houston, TX, 77058-2069, United States

    Description

    VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    Reason

    Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.

    Code Info

    Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500

    Distribution

    US Distribution to the states of : CO and ND

    Quantity

    2 units