Events

Safety Alert for SYNCHROMED Implantable Infusion Pump.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Planta Neuromodulação, Medtronic Inc.; 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
    1578
  • Date
    2015-05-15
  • 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
    Company Information: As per the agreement published by the FDA itself (available for access at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444690.htm) on April 27, 2015, Medtronic needs to complete certain corrections and improvements to the SynchroMed pump and the Neuromodulation Quality System to comply with FDA regulations for medical devices. The decree calls for changes in product design that will include changes to address previously reported problems through medical device correction notices, which can be found at http://professional.medtronic.com/neuro/idd/ind/product- advisories. In addition, the agreement also requires Medtronic to hire the services of an independent expert to inspect the Neuromodulation Quality System and its processes and records and to obtain certification ensuring that the system complies with the requirements of the decree. Once the compliance of the Medtronic Neuromodulation Quality System has been proven to FDA satisfaction, the limitations on the manufacture and distribution of SynchroMed pumps will be terminated. Medtronic Comercial Ltda reported that it did not import the products of the Columbia Heights, Minnesota / USA plant (plant affected by consent decree), since it was not requested to certify the GMP of said plant until the present moment, and also for not be one of the manufacturers approved by ANVISA. Under this agreement with the US FDA, Medtronic may continue to manufacture and supply SynchroMed drug infusion pumps to patients who have the product implanted and in need of a replacement as well as to new patients when under conditions of medical necessity . The agreement with the FDA is specific to the SynchroMed drug infusion system and does not include any other Medtronic product or business. Anvisa emphasizes that the measures adopted in the consent decree are applicable to the US and that, in Brazil, the case is under evaluation by ANVISA. This alert will be updated as new information becomes available.
  • Reason
    The us food and drug administration (fda) has established a consent decree with medtronic, which has established limitations on the manufacture and distribution of synchromed pumps in the usa.
  • Action
    The company Medtronic Comercial Ltda has forwarded information on the subject to Anvisa, which are under evaluation. There is currently no information to indicate any problem or restriction of use of SYNCHROMED pumps. Users of the product should continue their use normally, following the instructions for use of the product.

Device

SYNCHROMED Implantable Infusion Pump.

Manufacturer

Planta Neuromodulação, Medtronic Inc.; 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