BEUDAMED
    FDA Enforcement Class II Terminated

    SynchroMed II implantable drug infusion pump, Model 8637-40,

    Recall: Z-1694-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1694-2017
    Event ID
    76591
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 5, 2017
    Initiation Date
    February 9, 2017
    Classification Date
    March 29, 2017
    Termination Date
    September 4, 2018
    Address
    7000 Central Ave, Minneapolis, MN, 55421-1241, United States

    Description

    SynchroMed II implantable drug infusion pump, Model 8637-40,

    Reason

    Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.

    Code Info

    Serial Number NGV526743H

    Distribution

    IL

    Quantity

    1