Alerta De Seguridad O Notificaciones De Seguridad para N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders neurostimulator programmers

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
    An error in the programmer software (revision NNB_01) may lead to false warnings of a low battery status. There is a risk that pre-existing symptoms may return if the device ceases to function when true low or end of service battery warnings are subsequently ignored.There are three ways to measure battery status in the model 3023 InterStim neurostimulator:using the InterStim iCon patient programmer
    Automated Measurement feature on N’Vision clinician programmer
    Therapy Measurement feature on N’Vision clinician programmer.Medtronic has identified that only the Therapy Measurement feature on the N’Vision programmer is accurate. It is therefore important to interpret all other low battery warnings with caution.In July 2007 Medtronic issued a Field Safety Notice (FSN) to alert users to the potential for false low battery warnings on the clinician and patient programmers and to advise of an accurate way to assess the battery capacity on the clinician programmer (see Appendix). Clinicians were advised that patients experiencing a low battery warning on their programmer (which were subsequently confirmed as false in clinic) should ignore further low battery warnings. The FSN also advised that new software was in development for both clinician and patient programmers to address the issue.In July 2008 Medtronic advised the MHRA that the software upgrade was in the approval process and would not be available for implementation for a further few months.It is possible that some model 3023 InterStim devices are now nearing the end of their life, and so genuine low battery alerts may be ignored (although it should be noted that the end of service (EOS) battery alert on the iCon programmer is valid). This could lead to a device ceasing to function before it can be replaced, and a return of the patient’s pre-existing symptoms.
  • Causa
    (medtronic) error in the programmer software (revision nnb_01) which may lead to false warnings of a low battery status. (mda/2008/065).
  • Acción
    You should:consider the need for in clinic review of battery status for patients who have received multiple low battery alerts on their iCon programmer or if their neurostimulator has been implanted for more than two years confirm battery status using the N’Vision Therapy Measurement feature, which is a reliable indicator - do not rely on the N’Vision low battery alert in the Automated Measurement feature to assess battery status


  • Modelo / Serial
  • Descripción del producto
    Medtronic N’Vision® clinician programmer (fitted with the InterStim B software – 8870 NNB_01 application card) and InterStim iCon® patient programmer (model 3037) when used with InterStim implantable neurostimulator (model 3023) for pelvic floor disorders.
  • Manufacturer


  • Dirección del fabricante
    Dr David Dunham Regulatory Affairs Manager – UK & IrelandMedtronic Limited Suite One Sherbourne House Croxley Business Centre Watford Herts WD18 8WWTel: 01923 212 213 Fax: 01923 241 004 E-mail:
  • 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