Events

Recall of ENTRUST SINGLE CHMBR IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA 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
    42873
  • Event Risk Class
    II
  • Event Initiated Date
    2012-03-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The purpose of this action is inform physicians who have implanted or follow patients implanted with entrust icds that a small percentage of those devices may not meet expected longevity or provide at least three months of device operation between the elective replacement indicator (eri) and end of life (eol) due to a more-rapid-than-expected drop in battery voltage. medtronic also provides following patient management recommendations: o physicians should continue routine follow-up sessions at least every three months in accordance with product labelling . o physicians should program the audible patient alerts for "low battery voltage eri" and "excessive charge time eol" to on. o physicians should replace devices promptly after they reach eri if the decline in voltage is more rapid than expected. o prophylactic replacement of entrust icds is not recommended.

Device

ENTRUST SINGLE CHMBR IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.
  • Model / Serial
    Model Catalog: D153VRC (Lot serial: All Lots); Model Catalog: D154ATG (Lot serial: All Lots); Model Catalog: D153ATG (Lot serial: All Lots); Model Catalog: D154VRC (Lot serial: All Lots); Model Catalog: D154DRG (Lot serial: All Lots); Model Catalog: D153DRG (Lot serial: All Lots)
  • Product Description
    ENTRUST SINGLE CHMBR IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • 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
    HC