Events

Safety Alert for external communicator for implantable cardiac devices

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
    I1606-244
  • Event Number
    2014DM-0011380
  • Date
    2016-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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 reports that it has identified a problem with the software that prevents the doctor from accessing the data of the device located in the carelink network, the transmission appears successfully for the patients, while in reality the transmitted data (carealerts) are not visible for the establishment of health, only monitors related to the implantable cardioverter defibrillator (icd) or the cardiac re-synchronization defibrillator (crt-d), which received software updates are unaffected, leading to potential adverse events being presented to patients.

Device

external communicator for implantable cardiac devices
  • Model / Serial
    24950
  • Product Description
    The monitor is an external electronic device that communicates with MEDTRONIC implanted cardiac devices and with a telecommunications connection to transmit to the physician the data stored in the implanted cardiac device.
  • Manufacturer
    Plexus Manufacturing Sdn, Bhd || Medtronic Inc

Manufacturer

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