Events

Safety Alert for NIM non-invasive nerve monitoring equipment Medtronic Xomed

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Advance Biopolymers S.R.L.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1606-267
  • Event Number
    2009DM-0003762
  • Date
    2016-06-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer who has identified a problem with excessive flexing of the tube by the user, especially at a sharp or abrupt angle, can cause the electrode wires to flow into its channel in the silicone wall, leading to potential adverse events occurring in patients.

Device

NIM non-invasive nerve monitoring equipment Medtronic Xomed
  • Model / Serial
    Endotracheal Tube of EMG Reinforced NIM Standard and Contact, models 8229306, 8229307, 8229308, || 8229506, 8229507 and 8229508, specific lots.
  • Product Description
    This device is intended for the supervision of surgical procedures for patients who require intraoperative monitoring of nerves, whose nature is non-invasive, assisting the surgeon in the location and mapping of the motor nerves through the use of EMG signals and electrical nerve stimulation. This equipment is accompanied by a series of accessories that connect to the patient in order to carry out the follow-up through the different measurements that the device performs.
  • Manufacturer
    Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Advance Biopolymers S.R.L

Manufacturer

Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Ad...
  • Source
    NIDFSINVIMA