Events

Safety Alert for Consulta CRT-P

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
    2013-06-18
  • Event Date Posted
    2013-06-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130618a.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 consulta crt-p the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning consulta crt-p [model no.: c3tr01 & serial no.: pzi614815s], manufactured by medtronic. the manufacturer recently identified an issue with a subset of consulta crt-p devices during production. this issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. an out-of-specification weld could result in a loss of device hermeticity and compromised device functionality. the manufacturer is requiring the return of non-implanted devices manufactured between april 1 and may 13, 2013 for re-inspection. furthermore, the manufacturer advises patients implanted with consulta crt-p device to continue to be followed regularly in accordance with product labelling. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00572-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 jun 2013.

Device

Consulta CRT-P
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Consulta CRT-P
  • 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