BEUDAMED
    FDA Enforcement Class II Terminated

    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    Recall: Z-2719-2014 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-2719-2014
    Event ID
    69025
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St. Jude Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2014
    Initiation Date
    July 29, 2014
    Classification Date
    September 29, 2014
    Termination Date
    August 21, 2015
    Address
    6901 Preston Rd, N/A, Plano, TX, 75024-2508, United States

    Description

    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    Reason

    The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.

    Code Info

    Material 100077108, Batch 4519182

    Distribution

    Distributed in the states of Texas and Illinois.

    Quantity

    4 units