Events

Safety Alert for Single Chamber Temporary External Pacemaker 53401

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

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
    2018-06-22
  • Event Date Posted
    2018-06-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180622b.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 single chamber temporary external pacemaker 53401 medical device manufacturer, medtronic limited, has issued a medical device safety alert concerning its single chamber temporary external pacemaker 53401 [serial numbers lower than mdb05000; distributed between february 2017 and november 2017]. the manufacturer advises users of the potential that a subset of medtronic model 53401 single chamber external pulse generators (epgs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected power on reset (por). the initial version of 53401 epg firmware was configured to allow an unused, unterminated digital input/output pin to be an input. during investigation of the issue, the unterminated pin was found to act as an antenna, which could detect external electrical signals. according to the manufacturer, the 53401 epg microprocessor expects the unterminated pin to be silent. when the unterminated pin detects electrical signals, device firmware may lock up and cause a por. when the epg experiences a por, by design, the device will cease functioning for approximately 7 seconds while it reboots, then resume functioning at nominal settings. through 21 may 2018, there have been 17 confirmed reports of this issue. no patient deaths or complications have been reported as a result of this issue. the manufacturer has received approval for a firmware correction that prevents occurrence of the issue. the affected users are recommended to send affected devices to the manufacturer’s service to update the firmware to prevent the issue. patients being treated with affected 53401 epgs should be continuously monitored per labeled instructions for use. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2018.

Device

Single Chamber Temporary External Pacemaker 53401
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Single Chamber Temporary External Pacemaker 53401
  • Manufacturer
    Medtronic Limited

Manufacturer

Medtronic Limited
  • 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