BEUDAMED
    FDA Recall Terminated

    Eon Rechargeable Implantable Pulse Generator (IPG) System

    Recall: Z-0170-2010 · Initiated December 22, 2006

    Recall

    Recall Number
    Z-0170-2010
    Event Number
    53128
    Firm
    Advanced Neuromodulation Systems, Inc
    FEI Number
    1627487
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 22, 2006
    Posted
    November 10, 2009
    Terminated
    July 23, 2010
    Address
    6901 Preston Rd, Plano, TX, 75024-2508

    Description

    Eon Rechargeable Implantable Pulse Generator (IPG) System

    Reason

    Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system.

    Action

    12/22/2006, Marketing Update 5015 was issued to field sales representatives providing information on improving communication between the Internal Pulse Generator and its charger. May 15, 2007, Marketing Update 5022 was issued to field sales representatives to reiterate avoiding contact between the charger antenna and conductive materials and place the preferred side of the charging antenna face-down over the implant. Troubleshooting Guide was created in January 2008 for field sales representatives and technical services departments regarding isolation of the communication issue to the external devices instead of the implanted component. March 25, 2008, the Clinician's Manual was updated adding a recommendation for a minimum depth of pocket for device implantation.

    Distribution

    Worldwide

    Quantity

    24,750 units total