BEUDAMED
    FDA Recall Terminated

    VNS Therapy Programmer, Model 3000, v1.0 System

    Recall: Z-2255-2018 · Initiated November 13, 2017

    Recall

    Recall Number
    Z-2255-2018
    Event Number
    80062
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    MUZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 13, 2017
    Terminated
    October 31, 2022
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy Programmer, Model 3000, v1.0 System

    Reason

    Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).

    Action

    On November 13, 2017 LivaNva sent letters to all the doctor and surgeons that use this device. "Dear Doctor: This notification describes an issue identified with the VNS Therapy Programmer, Model 3000 version 1.0 which may impact patients implanted with Models 103, 104, 105 or 106 VNS Therapy generators. This issue does not affect Model 1000 SenTiva or Model 102/102R generators. What is the Issue? Certain programming events performed with a Model 3000 Programmer on a Model 103, 104, 105 or 106 VNS Therapy generator can result in a miscalculation of some parameters stored in the generator, which could lead to: " Output current delivered being different than that programmed; " Device disablement; and/or " Errors in the 75% and 50% battery life indicators. The actual battery life and battery function are not affected by this issue. Risk to Health This issue presents the following risks: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects 1 (Model 106 only); " No stimulation in the case of device disablement, resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved (Models 103, 104, 105 or 106) ; or " Sudden decrease from 100% to 25% battery life indicator, though the actual battery life and battery function are not affected (Models 103, 104, 105). Which Patients are Potentially Impacted? Any patient with a Model 103, 104, 105 or 106 generator that has been programmed using a Model 3000 programmer may be affected by this issue. Your LivaNova representative will collect data from your Model 3000 programmer to identify which patients are impacted by this notice. Actions to be taken by the Physician 1. Stop using the Model 3000 programmer to program Model 103, 104, 105 or 106 generators. You shall continue using the Model 3000 programmer with Model 1000 SenTiva generators and may continue to use it wi

    Distribution

    AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI

    Quantity

    252