Events

Safety Alert for Name: Generators for Spinal Cord Stimulation RM / Programmable Neurostimulator medtronic / Active Neurostimulator Technical Name: Implantable Pulse Generator for Neurostimulation Registration Number ANVISA: 10339190453 (model 97754) / 10339190310 (model 37754) / 10339190338 (model 37651) Class risk: IV

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
    2064
  • Date
    2016-10-17
  • 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
    #### UPDATED ON 7/24/2017, the company submitted the field action completion report verifying the sending of the customer safety notice. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    This field action is intended to provide important information about the noise response and beeper issue of the model 37751 chargers. this letter contains information on how to prevent this problem from occurring and how to restore the charger's operation if such an event occurs . the model 37751 chargers are sold as a kit with the model 37754 and 97754 charge systems for spinal cord stimulation (scs) and are also sold as a kit with the model 37651 charging system for deep brain stimulation (ecp).
  • Action
    Field Action Code FA735 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. The company will make recommendations to health professionals.

Device

Name: Generators for Spinal Cord Stimulation RM / Programmable Neurostimulator medtronic / Active...

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