Events

Safety Alert for 5392 Dual-Chamber External Pulse Generator

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

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
  • Date
    2015-03-16
  • Event Date Posted
    2015-03-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150316b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic model 5392 dual-chamber external pulse generator medical device manufacturer, medtronic, has issued a medical device safety alert concerning model 5392 dual-chamber external pulse generator (epg) [serial number equal or lower than djh009999p]. the manufacturer has received reports that the negative terminal of a commercially available aa (lr6) battery did not maintain sufficient connection with the battery drawer electrical contact. this could prevent the epg from powering on or cause the epg to abruptly lose primary battery power, potentially stopping delivery of pacing therapy. the manufacturer advises users to use aa (lr6) batteries where the negative terminal does not have an indentation and has also introduced a new battery drawer contact that is compatible with all aa (lr6) batteries. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2015.

Device

5392 Dual-Chamber External Pulse Generator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Model 5392 Dual-Chamber External Pulse Generator
  • 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
    DH