Events

Alerta De Seguridad para Deep Brain Stimulation system extensions

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

¿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
    2015-04-16
  • Fecha de publicación del evento
    2015-04-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150416.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 neuromodulation deep brain stimulation system extensions medical device manufacturer, medtronic, has issued a medical device safety alert concerning neuromodulation deep brain stimulation system extensions [model number: 37085 and 37086 which can be used with neurostimulators: activa pc (model 37601), activa rc (model 37612) and the activa sc (model 37603)]. the manufacturer received complaints of high impedance of extensions and has completed analysis of the 14 extensions returned between october 1st, 2014 and march 2nd, 2015. high impedance for 13 of the extensions was observed at implant and one extension after approximately two months from implant. the manufacturer’s analysis of the returned extensions identified conductor wire fractures in close proximity to the location where the extension exits the connector block and not within the connector block itself. this issue may result in prolonged surgical procedure or revision surgery depending on when the high impedance / damage is detected. if a damaged extension is not detected during the implant procedure, it could result in loss of stimulation. the manufacturer advises users to follow the instructions defined within the neurostimulator implant manual related to extension implantation, specifically to ensure that the extension is not bent sharply or kinked to minimize the potential for a conductor wire fracture and to check electrode impedances for open circuits, prior to pocket closure, which could indicate a potential conductor fracture. according to the local supplier, 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 april 2015.

Device

Deep Brain Stimulation system extensions
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Neuromodulation Deep Brain Stimulation system extensions
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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