BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1694-2017 · Initiated February 9, 2017

    Recall

    Recall Number
    Z-1694-2017
    Event Number
    76591
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 9, 2017
    Terminated
    September 4, 2018
    Address
    7000 Central Ave, Minneapolis, MN, 55421-1241

    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.

    Action

    A Medtronic representative visited the clinic on 2/9/2017 and corrected the SynchroMed II pump by resetting the pump memory using a SynchroMed Lab Programmer running on a Medtronic laptop with a validated protocol. Consignee was given a Medtronic "Urgent Medical Device Correction" letter dated February 8, 2017. The letter described the Issue and Actions to be taken by the consignee. For questions contact your Medtronic Representative Medtronic or Neuromodulation Technical Services at 1-800-707-0933.

    Distribution

    IL

    Quantity

    1