Events

Safety Alert for Extensions DBS - Deep Brain Stimulation System. Anvisa Registry n ° 10339190320. Models under risk: 37085 and 37086.

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

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
    1575
  • Date
    2015-05-12
  • 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
    Medtronic has completed the review of fourteen (14) extensions between October 1, 2014 and March 2, 2015 for high impedance complaints. According to client reports, the high impedance for thirteen (13) of the extensions was observed in the implant and one extension after approximately two months of implantation. Medtronic's analysis of returned extensions identified conductor wire fractures near the location where the extension exits the connector block and not within the connector block itself. In all fourteen (14) cases (occurrence rate of 0.14%), extension was reported to have been successfully replaced, but resulted in a prolonged surgical procedure for thirteen (13) cases and one revision surgery for one approximately two months from the implant. The investigation of Medtronic's root cause of this problem is under way. A damaged extension not detected during the implant procedure could result in loss of stimulation.
  • Reason
    Possibility of fractures occurring in the conductor wire, near the location where the extension exits the connector block.
  • Action
    The company is sending out Urgent Safety Notice letters to the customers involved in order to reinforce information on the handling of the product in question already on the product label. The current label for system handling during implantation is described within the implant manual, distributed with each device. To minimize the potential of a driver's wire fracture, you should follow the instructions in the Neurostimulator implant manual regarding the extension implant to specifically ensure that the extension does not bend too much or bend. For more detailed information, refer to the Safety Notice issued by the company at: http://portal.anvisa.gov.br/wps/connect/c6b5c9804859842faa60ab734e60b39c/FA648+-+Professional++++++++++++++++++++++++++++++++ BAde.pdf? MOD = AJPERES

Device

Extensions DBS - Deep Brain Stimulation System. Anvisa Registry n ° 10339190320. Models under ris...

Manufacturer

Medtronic Comercial Ltda.; Medtronic Puerto Rico operations Co. MPRI
  • 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