Alerta De Seguridad para SynchroMed II Implantable Drug Infusion Pump

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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 synchromed ii implantable drug infusion pump medical device manufacturer, medtronic, has issued a medical device safety alert concerning its synchromed ii implantable drug infusion pump [model numbers: 8637-20 and 8637-40]. the manufacturer has received approval to implement a design change to the synchromed ii implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy. for pumps manufactured prior to this design change, analysis of the post-market data estimates the pump survivability specific to non-recoverable motor stall at six years post-implant to be 97.3% for pumps exposed to on-label drugs and 91.1% for pumps exposed to off-label drugs. the most common contributing factor to motor stall is shaft wear and this is observed in 59% of synchromed ii pumps returned and analyzed for motor stall. engineering testing estimates that the new design change addresses over 99% of shaft wear and will decrease the occurrence of motor stall. the manufacturer recommends the synchromed ii infusion system be used according to approved product labeling. reliability for synchromed ii pumps used with off-label drugs will still be lower than pumps used with on-label drugs, regardless of indication. according to the manufacturer, all synchromed ii pumps are now manufactured with the new design change, although there are limited quantities of these new devices in initial production. to ensure the patients have access to uninterrupted therapy, pumps manufactured prior to this latest change will remain available. once there is sufficient inventory of the pumps with the new design, the manufacturer will no longer distribute pumps manufactured prior to this change. 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 15 september 2017.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic SynchroMed II Implantable Drug Infusion Pump
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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