Events

Notificaciones De Seguridad De Campo acerca de Pacemakers

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Boston Scientific.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Boston scientific has received reports of occasional over-sensitivity of the minute ventilation (mv) sensor signal at certain boston scientific pacemakers and pacemaker systems for cardiac resynchronization therapy (pacemakers). excessive sensitivity of the mv sensor signal may lead to pre-collapse or collapse due to periods of inhibition. this mv behavior can occur with any manufacturer's pacemaker buses, but boston scientific pacemakers using medtronic or abbott / st. pacemakers are more likely. jude (abbott) guides implanted in right atrium (da) or right ventricle (dp). boston scientific is actively developing a software update that will automatically detect and eliminate the over-sensitivity of the mv sensor signal. we plan to send the software update to regulatory agencies in march 2018, and with their approval, we plan to release it in october 2018. until the software update is available, boston scientific has additional recommendations to prevent this risk in affected pacemaker systems.

Device

Pacemakers

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • 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
    AMPMDRS