BEUDAMED
    FDA Recall Open, Classified

    VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

    Recall: Z-0663-2020 · Initiated November 16, 2018

    Recall

    Recall Number
    Z-0663-2020
    Event Number
    84170
    Firm
    LivaNova USA Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 16, 2018
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

    Reason

    This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.

    Action

    On November 16, 2018 LivaNova mailed a "Medical Device Correction" letter via 1st class mail to affected Doctors informing them about the recall. The letter asked doctor's to do the following: 1.When performing System Diagnostics on patients implanted with a Model 102 or 102R generator, do one of the following: a. Use any of the following Programming System software versions: Model 250 8.1/11.0; Model 3000 version 1.0; or b. If one of the above Programming Systems software versions is not available, complete the following steps to perform System Diagnostics using Model 3000 version 1.5 software: i. Interrogate the device, noting the devices current settings, ii. Program normal mode output current to 0mA, iii. Perform System Diagnostics as usual, iv. Re-interrogate the device, v. Program the devices normal mode output current back to the settings noted in step (i) above, and; vi. Interrogate the device to verify settings are as intended prior to the patient leaving the office visit. 2. Please complete and return the attached Customer Response Form by fax to 281-853-1248 or by e-mail to [email protected]. 3. Please ensure that this notice is communicated to all personnel within your organization who need to be aware of it. 4. For questions regarding the information in this letter, please contact Clinical Technical Support at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at [email protected].

    Distribution

    IL, AK, AL, AR, AZ, CA, CA , CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD MI, MN, MO, MS, MT, NC, ND, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA , WI, WV, WY,

    Quantity

    643 units