Events

Safety Alert for MyCareLink Remote Monitors

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Plexus Manufacturing Sdn, Bhd || Medtronic Inc.

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
    I1707-305
  • Event Number
    2014DM-0011380 ; 2017DM-0015831
  • Date
    2017-07-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=78
  • 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

Device

MyCareLink Remote Monitors
  • Model / Serial
    24950 and 25000, all serials.
  • Product Description
    The monitor is an external electronic device that communicates with the implanted cardiac devices of MEDTRONIC and with a telecommunications connection to transmit to the doctor the data stored in the implanted cardiac device.
  • Manufacturer
    Plexus Manufacturing Sdn, Bhd || Medtronic Inc

Manufacturer

Plexus Manufacturing Sdn, Bhd || Medtronic Inc
  • Source
    NIDFSINVIMA