Safety Alert for Product name: Implantable Neurostimulator for Deep Brain Stimulation (Anvisa registration number: 10339190485), Active Rechargeable Programmable Neurostimulator RC (Anvisa record number: 10339190528), Activa® SC Programmable Neurostimulator (Anvisa registration number: 10339190338), DBS Extension Kit for Deep Brain Stimulation (Anvisa registration number: 10339190463); Neurostimulator Medtronic Spelling Model 7426 (Anvisa registration number: 10339190191), Medtronic Kinetra Neurostimulator Model 7428 (Anvisa registration number: 10339190152) /// Lots: ALL LOTS /// Product risk class: IV - maximum risk.

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.; Medtronic Neuromodulation; Medtronic Puerto Rico Operations Co; Medtronic Puerto Rico Operations Co.

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
    1904
  • Date
    2016-05-25
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    As a recommendation to users and patients, the company clarifies that "Loss of coordination may be a side effect of DBS therapy and may result, for example, in inability to swim. Patients should be aware that participating in any activities that require coordination that they were previously able to perform may put them in an undue situation. Therefore, these activities should be performed under supervision after DBS therapy is initiated for the first time and after scheduling changes until the effects of DBS therapy on coordination are understood./// During DBS implantation, the DBS health should be cautious during the tunneling of the extension of the electrode to the SNI to prevent tunneling from becoming too deep or too superficial, as this could lead to serious injury. Complications or effects related to the tunneling procedure may include injury to nerve tissue (such as the accessory nerve of the spine), vascular injury that can result in prolonged hospitalization and tunneling through an unwanted anatomy (such as between the ribs and into the thoracic cavity).
  • Reason
    These are two field actions (fa 711 and fa712). the first is intended to "notify information that will be included in the medtronic deep brain stimulation (dbs) label in connection with the activa® pc, activa® sc and activa® rc devices. this information also applies to patients previously implanted with the kinetra® and soletra® devices. the update concerns an event reported on inability to swim after implantation and the initiation of dbs therapy for parkinson's disease in an experienced swimmer. the patient achieved an excellent result with dbs therapy to control the symptoms of the disease and did not present evidence of the specific motor coordination symptoms identified in the dbs labeling. " the second objective is to "notify information that will be included in medtronic's brain deep stimulation (dbs) label in connection with the tunneling procedure related to dbs extensions model 37086. the labeling updates also clarify possible risks that have been reported with the dbs implant procedure. " the company's goal in sharing this information is to assist the user in the dbs procedure, patient selection, informed consent, and post-implant follow-up of patients treated with dbs therapy. " the conclusion of the company's risk assessment for tunneling is as follows: "post-marketing surveillance of medtronic for dbs therapy has identified the following events or serious injuries associated with tunneling not present in the current dbs labeling. the following events are associated with the dbs implant and the tunneling of the extension of the electrode to the ni (implantable neurostimulator): cases of accessory nerve injury of the spine; severe bleeding or vascular injury; an extension implanted incorrectly through the ribs and that is next observed near the heart that requires an evaluation; very superficial tunneling resulting in an extension that came out and entered again in the neck and that had not been discovered until the removal of the surgical dressing. these events occurred in approximately 0.008% of the tunneling procedures. note: the specific model of the tunneling tool associated with patient injuries has not been reported in many of these events. thus, medtronic is intended to notify you of information that will later be included in the brain deep stimulation (dbs) labeling in connection with the tunneling procedure related to dbs extensions model 37086. ".
  • Action
    Action code: FA 711 and FA712 /// Classification of field action: Update, correction or supplementation of instructions for use /// Loss of coordination may be a side effect of DBS therapy and may result, for example, in inability to swim. Patients should be aware that participation in any activities that require coordination that they were previously able to perform may put them in an undue situation; therefore, these activities should be performed under supervision after DBS therapy is initiated for the first time and after scheduling changes until the effects of DBS therapy on coordination are understood. During the implantation of DBS, the healthcare professional should be cautious during the tunneling of the extension of the electrode to the SNI to prevent the tunneling from becoming too deep or too superficial, as this could lead to serious injury. Complications or effects related to the tunneling procedure may include injury to nerve tissue (such as the accessory nerve of the spine), vascular injury that can result in prolonged hospitalization and tunneling through an unwanted anatomy (such as between the ribs and into the thoracic cavity). / / LETTER TO THE CUSTOMER IN ANNEX.

Manufacturer

  • Manufacturer Parent Company (2017)
  • 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