BEUDAMED
    FDA Recall Terminated

    VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software

    Recall: Z-1591-2010 · Initiated April 6, 2010

    Recall

    Recall Number
    Z-1591-2010
    Event Number
    55446
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 6, 2010
    Posted
    May 10, 2010
    Terminated
    August 20, 2012
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software

    Reason

    Battery life projection is inaccurate.

    Action

    Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic. The issue can also be corrected during the initial implant procedure with the instructions provided. Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.

    Distribution

    Worldwide distribution.

    Quantity

    Model103: 8109 units; Model 104: 1722 units; Programmers: 8891