Events

Safety Alert for Temporary endocardial stimulation cable system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic France S.

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
    R1606-252
  • Event Number
    2005V-0003497
  • Date
    2016-05-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • 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 detected that the referenced device does not meet the requirements of section 8.5.2.3 of the international standard iec 60601-1 and the corresponding provision 21 crf 898 of the fda in relation to the design standards to prevent the connection of the patient's cable to possibly dangerous voltages, this situation could be possible if the instructions for use are not followed properly, leading to the potential occurrence of adverse events on patients.

Device

Temporary endocardial stimulation cable system
  • Model / Serial
    6416, all batches manufactured after May 1, 2014
  • Product Description
    The MEDTRONIC model 6416 temporary transvenous stimulation cable system has a bipolar active fixation cable and a lubri- cated lubricant guide catheter. This system has been designed for temporary intracardiac stimulation and the recording of electrocardiograms. It is a disposable system, for temporary use with only one patient, with an estimated implant duration of 7 days or less.
  • Manufacturer
    Medtronic France S

Manufacturer

Medtronic France S
  • 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