Alerta De Seguridad para subcutaneous implantable defibrillator system

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

¿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: boston scientific subcutaneous implantable defibrillator system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the subcutaneous implantable defibrillator system, manufactured by boston scientific. according to the manufacturer, a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. the fuse has been unintentionally activated once during an implant procedure and three times post-implant out of approximately 1,900 devices implanted worldwide. all three post-implant events occurred within one month of implant. the defibrillator may not be able to deliver therapy or communicate with the q-tech model 2020 programmer, and may be unable to emit tones or otherwise respond to magnet application. no patient deaths or injuries have been reported as a result of this behavior. a non-invasive, software-based mitigation (version 1.95.0) has been developed to protect the fuse from unintended activation. local sales representative will install this new software on all q-tech model 2020 programmers located at the hospital/clinic. furthermore, the manufacturer has the following recommendations for healthcare professionals: for patients whose device has been implanted for less than three months, it is recommended to schedule a follow-up visit as soon as possible within the next six weeks for patients whose device has been implanted for three months or more, ensure the next scheduled visit occurs within three months of the previous visit, as recommended in device labeling at the next follow-up visit, interrogate each patient’s device using a programmer with version 1.95.0 software. interrogation with an updated programmer will automatically add the new software to the implanted device. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con244550 if you are in possession of the product, please contact your supplier for necessary actions. posted on 12 march 2013.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific subcutaneous implantable defibrillator system
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source