Events

Safety Alert for Trade name: DBS ELETRODE FOR DEEP BRAIN STIMULATION; DEEP BRAIN STIMULATION ELECTRODE; KIT CATETER DBS ELECTRODE FOR DEEP BRAIN STIMULATION Technical name: DBS ELETRODE FOR DEEP BRAIN STIMULATION; DEEP BRAIN STIMULATION ELECTRODE; KIT CATETER DBS ELECTRODE FOR DEEP BRAIN STIMULATION ANVISA registration number: 10339190484; 10339190549; 10339190339 Hazard Class: IV Affected Model: 3387S-40, 3389S-28, 3389S-40 and 3391S-40

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA; Medtronic Inc..

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
    2231
  • Date
    2017-03-17
  • 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
    If your surgical procedure involves the use of Medtronic's DBS depth limiter, Medtronic recommends the following: • For the implanted product: If the product has already been implanted, no action is necessary once the electrode placement at the target site was confirmed by intraoperative test stimulus, imaging and / or efficacy of the therapy. • For the product to be implanted: If it is suspected that the depth limiter has not been properly attached to the electrode, do not use and complete the procedure using a depth limiter from another Medtronic DBS electrode kit. As stated in the DBS electrode implant manual, Medtronic recommends checking the effect of the stimulus during the implant procedure and using imaging techniques to confirm electrode placement. #### UPDATED ON 7/24/2017, Medtronic Company submitted the field action completion report verifying the submission of the safety notice.
  • Reason
    The medtronic dbs depth limiter, also referred to as electrode holder, is used to establish the depth of the implant. the depth limiter interacts with parts of the stereotactic system used during surgery to control the placement of the tip of the dbs electrode at the target site. this letter provides information regarding a product performance problem that has been identified in this component, potential patient risks, and actions to be taken in connection with the use of medtronic's depth limiter.
  • Action
    Field Action Code FA761 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will update, correct or supplement the instructions for use.

Device

Trade name: DBS ELETRODE FOR DEEP BRAIN STIMULATION; DEEP BRAIN STIMULATION ELECTRODE; KIT CATETE...

Manufacturer

MEDTRONIC COMERCIAL LTDA; Medtronic Inc.
  • 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