Events

Field Safety Notices about Single Chamber External Pulse Generator

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Medtronic.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Medtronic has detected a problem with a device potentially affecting older single-chamber temporary pacemakers ("epgs"), model 5348, manufactured between july 1995 and december 2007. by april 16, 2014, medtronic identified 49 adverse events (out of about 30,000 potentially affected model 5348 epgs, or 0.16 percent) that related to a deviation from the programmed electrostimulation frequency, including sudden events elevated electrostimulation frequencies up to a maximum of 180 beats per minute. of those 49 events, (two cases were reported in france and the other 47 were reported outside the eu), one was associated with the death of patients and no other critical injury reports were reported. the manufacturer has received 85 more reports of electrostimulation frequency deviation of programmed value, which may have been related to this problem but were not confirmed due to insufficient data.

Device

Single Chamber External Pulse Generator
  • Model / Serial
    Model: 5348
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    ALIMSA