Events

Notificaciones De Seguridad De Campo acerca de SynchroMed® II and SynchroMed EL Implantable Drug Pumps

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Medtronic Limited.

¿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
  • Número del evento
    SN2013(07)
  • Fecha
    2013-07-11
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/synchromed-ii-and-synchromed-el-implantable-drug-pumps&id=5a7bf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    Four communications to help identify and manage issues that may impact the safe delivery of therapy using the synchromed® ii and synchromed el implantable drug pumps.
  • Acción
    The IMB recommends that:  1. Relevant personnel in your organisation are made aware of these potential issues.  2. The device and patient management advice outlined in the Medtronic Communications is followed.  3. Unused sutureless connector catheters with a used by date prior to 25th August 2014 should be returned to Medtronic.  4. This IMB Safety Notice and the attached Field Safety Notices are passed on to any organisation or end user where the potentially affected devices have been transferred.

Device

SynchroMed® II and SynchroMed EL Implantable Drug Pumps

Manufacturer

Medtronic Limited
  • 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
    HPRA