Events

Recall of N'VISION APPLICATION CARD

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
    136010
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-26
  • 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 medical device correction includes the distribution of a new 8870 software application card version bbr/01 (revision b) which provides updates to the 8840 clinician programmer used to program medtronic spinal cord stimulators deep brain stimulators and the synchromedr ii implantable infusion system. for scs and dbs therapy: the new software provides an automatic transfer of new internal device software from the 8840 to implantable and implanted devices. this change addresses loss of stimulation caused by the exception bit behavior. this behavior is also known as error code 509. in addition the notification provides information about the potential for over stimulation or stimulation in the wrong area under a specific set of conditions typically related to device recovery from an over discharge. for synchromed ii pump therapy: the update includes correction of the issue previously communicated in the march 2012 medical device correction regarding the potential for the model 8840 n'vision clinician programmer to display an erroneous replace by date (erbd) "schedule to replace pump by" (date when used with the synchromed ii pump. the updated software also corrects the potential for premature low and empty reservoir alarms with the synchromed ii pump. these premature alarms are due to an incorrect calculation within the 8840 programmer software. no changes are being made to the implantable synchromedr ii pump device as a result of this update.

Device

N'VISION APPLICATION CARD
  • Model / Serial
    Model Catalog: 8870 (Lot serial: Not Applicable)
  • Product Description
    N'VISION APPLICATION CARD
  • 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