Events

Safety Alert for Implantable Cardioverter Defibrillator

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Inc. || Medtronic Europe S. A.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
    A1709-412
  • Event Number
    2017DM-0016423 ; 2017DM-0016469
  • Date
    2017-09-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=73
  • 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 has detected a software problem generated by a certain programming sequence that could lead to loss of stimulation in the left ventricle (lv) in all the referenced devices, for which it has already obtained the necessary approvals and is ready to start updating the software. all programmers to correct the problem, in order to reduce the risk of potentially serious adverse events occurring to patients.

Device

Implantable Cardioverter Defibrillator
  • Model / Serial
    Claria and Wide CRT-D MRI, serial RPB603896S, RPB603895S
  • Product Description
    The CLARIA MRI system is indicated for use in patients with a high risk of sudden death due to ventricular tachyarrhythmias and who suffer from heart failure with ventricular dyssynchrony. The device is designed to provide atrial, ventricular or both atrial pacing, cardioversion and defibrillation for the automatic treatment of atrial, ventricular tachyarrhythmias, or both, which may endanger the patient's life.
  • Manufacturer
    Medtronic Inc. || Medtronic Europe S. A.R.L

Manufacturer

Medtronic Inc. || Medtronic Europe S. A.R.L
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA