Events

Recall of Amplia MRI CRT-D series (DTMC 2 QQ Compania MRI Quad CRT-D IS 4 / DF 4)

According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in Japan that was produced by Japan Medtronic Co., Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    2-7021
  • Date
    2016-07-19
  • Event Country
    Japan
  • Event Source
    PMDAJ
  • Event Source URL
    http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-7021
  • Notes / Alerts
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, 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 Japan.
  • Extra notes in the data
    2016/9/21 Correction of "2. Target Lot, Quantity and Shipment Timing" Recovery End 2017/5/30 "2. Target Lot, Quantity and Shipment Time" "9. Person in Contact and Contact" Correction

Device

Amplia MRI CRT-D series (DTMC 2 QQ Compania MRI Quad CRT-D IS 4 / DF 4)
  • Model / Serial
  • Product Description
    Implantable biventricular pacing pulse generator with defibrillation function
  • Manufacturer
    Japan Medtronic Co., Ltd.

Manufacturer

Japan Medtronic Co., Ltd.
  • 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
    PMDAJ