Events

Alerta De Seguridad para Deep Brain Stimulation (DBS) system

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-05-16
  • Fecha de publicación del evento
    2016-05-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160516.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic deep brain stimulation (dbs) system medical device manufacturer, medtronic ltd, has issued a medical device safety alert concerning its deep brain stimulation (dbs) system. the safety alert relates to two separate issues: loss of coordination and the tunneling procedure of the dbs system. issue one - loss of coordination this issue relates to activa rc (37612), activa pc (37601), activa sc (37602 and 37603), activa pc+s (37604), kinetra (7428) and soletra (7426). the manufacturer has become aware of a reported event of inability to swim following dbs implantation and initiation of dbs therapy for parkinson’s disease in a patient who was an experienced swimmer. while the issue was identified in a patient being treated for parkinson’s disease (a movement disorder), it may apply to any approved dbs therapy indication. patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after dbs therapy is first turned on and after programming changes until any effects of their dbs therapy on coordination are understood. issue two - tunneling procedure this issue relates to dbs extensions models 7483 and 37086, tunneling tools 3755, 3550-05. the manufacturer’s post marketing surveillance for dbs therapy has identified the following serious events or injuries associated with tunneling that are not presented in the current dbs labeling. the following events are associated with the dbs implant and tunneling the extension from the lead to the implantable neurostimulator (ins): cases of spinal accessory nerve injury severe bleeding or vascular injury an extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision tunneling too superficially resulting in an extension that exited and then re-entered the neck which was not discovered until the surgical drape was removed. these events occurred in an estimated 0.008% of tunneling procedures. the manufacturer advises that during the dbs implant, users should be cautious while tunneling the extension from the lead to the ins to avoid tunneling too deeply or superficially because serious injury may occur. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 may 2016.

Device

Deep Brain Stimulation (DBS) system
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Deep Brain Stimulation (DBS) system
  • Manufacturer
    Medtronic Ltd

Manufacturer

Medtronic Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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
    DH