Events

Safety Alert for REVEAL LINQ Insertable Heart Monitor

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
    I1612-585
  • Event Number
    2014DM-0011606
  • Date
    2016-12-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=108
  • 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 states that it has identified a problem with the sensitivity of an algorithm used in the (icms), which may prematurely trigger the replacement time alert (rrt) on some devices. as of february 12, 2016, medtronic states that it has observed an occurrence rate of 0.45% of the devices that experience this problem, leading to the occurrence of possible serious adverse events on the patient.

Device

REVEAL LINQ Insertable Heart Monitor
  • Model / Serial
    LNQ11
  • Product Description
    The REVEAL LINQ cardiac monitor from MEDTRONIC is a programmable device that continuously monitors the ECG and other physiological parameters of the patient. The device registers cardiac in response to the activation of the patient and the arrhythmias that have been detected automatically. It is indicated in the following cases: Patients with clinical syndromes osituations with greater risk of cardiac arrhythmias. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
  • 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