Events

Safety Alert for APPLICATION CARD OF MODEL 8870 SOFTWARE USED IN MEDICAL PROGRAMMER 8840 N VISION. Related Appliances: SYNCHROMED II IMPUTABLE INFUSION PUMP (10339190229); ACTIVE PROGRAMMABLE NEUROSTIMULATOR (10339190338); MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (10339190310); PROGRAMMER N`VISION MEDTRONIC (10339190180).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Comercial Ltda..

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
  • Event ID
    1303
  • Date
    2013-10-04
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    Verify the details of the field action in the Medtronic Field Emergency Notification issued at Med.gov 08/27/2014: Field action completed by the company on 04/30/2014.
  • Reason
    Problems in the model 8870 software application card used in 8840 n'vision ™ medical programmer may lead to the following failures in the above devices: (1) in synchromed ii deployable infusion pumps: erroneous replacement by date and early / premature reservoir alarm ; (2) in programmable neurostimulators: loss of stimulation and excessive stimulation.
  • Action
    Medtronic is contacting its customers to begin updating the software.

Device

APPLICATION CARD OF MODEL 8870 SOFTWARE USED IN MEDICAL PROGRAMMER 8840 N VISION. Related Applian...

Manufacturer

Medtronic Comercial Ltda.
  • 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
    ANVSANVISA