BEUDAMED
    FDA Enforcement Class II Terminated

    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.

    Recall: Z-0894-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0894-2013
    Event ID
    61554
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Neuromodulation Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    March 28, 2012
    Classification Date
    February 28, 2013
    Termination Date
    August 15, 2013
    Address
    6901 Preston Rd, N/A, Plano, TX, 75024-2508, United States

    Description

    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.

    Reason

    Unintended Fluid ingress into the device header has been shown.

    Code Info

    Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.

    Distribution

    Worldwide Distribution - 53 consignees out of the US.

    Quantity

    388 units