Alerta De Seguridad O Notificaciones De Seguridad para Some EnRhythm® and EnRhythm MRI™ implantable pacemakers

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Medtronic.

¿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
    Safety alert / Field Safety Notice
  • Número del evento
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
    Following a software update the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI in some EnRhythm® and EnRhythm MRI™ devices.The manufacturer issued a Field Safety Notice (34Kb) (FSN) in August 2011 with patient management recommendations updated from a previously issued FSN (in February 2010), which informed healthcare professionals about a software update.The software update adds a battery impedance ERI threshold that may trigger an unexpected ERI in some devices. Medtronic’s modelling from collected data estimates that approximately 6–10% of devices may reach ERI within five years of implantation. When ERI is triggered, the device reverts to VVI back-up pacing mode (65 beats per minute) which may not be adequate treatment and may cause symptoms associated with pacemaker syndrome for some patients.These pacemakers are no longer sold in the UK and all devices supplied in the UK reached their use by date by 14 August 2011.
  • Causa
    (medtronic) a software update of the new battery impedance elective replacement indicator (eri) threshold may trigger an unexpected eri. (mda/2011/097).
  • Acción
    Schedule all patients who have received the software update for a follow-up visit to identify devices that triggered ERI shortly after the software update. Patients who have not yet received the software update should be reviewed, and then again within 90 days after the software update to identify if ERI is triggered.  Continue to follow up until device is ready for replacement: every three months if patient is pacemaker dependent, and every six months (or at individual physician’s discretion) if patient is not pacemaker dependent. Schedule device replacement when ERI is triggered.


  • Modelo / Serial
  • Descripción del producto
    Implantable pacemakers manufactured by Medtronic.EnRhythm®: Model P1501DR is a dual chamber rate responsive pacemaker.EnRhythm MRI™ SureScan: Model EMDR01 IPG is a modified EnRhythm® P1501DR which is MR Conditional.
  • Manufacturer


  • Dirección del fabricante
    Dr David Dunham / Mrs Lezlie Bridge Medtronic Limited Building 9 Croxley Green Business Centre Hatters Lane Watford WD18 8WW Tel: 01923 212 213 / 07740 899 216 Fax: 01923 241 004 / 01923 225 273Email: or
  • 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