Alerta De Seguridad O Notificaciones De Seguridad para Ellipse™ VR/DR implantable cardioverter defibrillators (ICDs)

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 St Jude Medical.

¿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
    Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.St Jude Medical issued a FSN dated 19 August 2014 (340Kb), describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.Affected devices have in most cases ‘recovered’ and perform normally after an extended charge timeout. From bench testing of returned devices, the manufacturer has confirmed that the likelihood of the ICD continuing to perform normally after an extended charge timeout is far greater among those ICDs with capacitors manufactured since a process improvement at the start of August 2012 (93% recovery), compared to those manufactured before (50% recovery).St Jude Medical will be able to provide advice for ICDs exhibiting extended charge times on whether the device incorporates the earlier or later more reliable capacitors. Subsequent automated or manual capacitor testing should also help demonstrate whether there is a persistent problem following an initial timeout event. In-clinic testing and reducing the capacitor maintenance interval to every 4 months (from the standard 6-monthly interval) will enable earlier detection of a possible problem, but it is important to be aware that their combined effect will reduce the remaining device longevity by almost 20%. Clinicians should take this into account in their management of individual patients.Any device that has experienced repeated, extended charge timeout warnings should be considered for replacement. Prophylactic explant is not generally recommended, but may need to be considered in exceptional circumstances such as for very high-risk patients, or those unable to cope with the psychological effects of this issue.
  • Causa
    (st jude medical) these defibrillators can delay or reduce the therapy that can be delivered by the icd.(mda/2014/035).
  • Acción
    Identify affected ICDs, and if any unimplanted devices are found these should be returned to St Jude Medical, as detailed in their FSN dated 19 August 2014 (340Kb). Identify affected patients and schedule them for a follow-up evaluation within 3 months to discuss this issue, giving priority to high-risk patients. Interrogate the ICD and perform a manual capacitor maintenance charge, noting the time to reach full charge. Contact St. Jude Medical’s technical support for further advice if the charge time exceeds 15 seconds or if an alert for ‘capacitor charge time limit reached’ is triggered. Consider replacing ICDs that have experienced repeated, extended charge timeout warnings. Ensure that appropriate vibratory alarms are enabled. Test the patient’s sensitivity to the alarm and remind them to contact their clinic immediately if it is triggered, as this could be due to a capacitor charge timeout. Ensure that Merlin remote monitoring is in place wherever possible and that remote monitoring alarms are enabled. Reduce the ICD’s automatic capacitor maintenance interval by reprogramming to every 4 months. Repeat the above patient review at normal follow-up intervals.


  • Modelo / Serial
  • Descripción del producto
    EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.Manufactured by St Jude Medical.
  • Manufacturer


  • Dirección del fabricante
    St Jude Medical UK Ltd Technical Services 0046 8 474 4147orSean Hogarth St Jude Medical UK Ltd Capulet House Stratford Business and Technology Park Stratford-upon-Avon, CV37 7GX Tel: 01789 207 600 Fax: 01789 207 601Email:
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source