Alerta De Seguridad O Notificaciones De Seguridad para Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D)

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
  • 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
    St Jude Medical issued a Field Safety Notice addressing this issue on 10th October 2016.Approximately 350,000 devices are estimated to remain implanted worldwide, manufactured between January 2010 and 23 May 2015, with just under 9,000 sold in the UK.
    Devices manufactured after 23 May 2015 are not affected due to a design improvement.Lithium clusters can occur in any high voltage device battery with lithium based chemistries. Factors such as the specific battery design and charge density can determine whether cluster formation presents a risk to battery performance. These clusters can induce a short circuit that causes premature battery depletion, depending on their location. The shorts are unpredictable, can drain the battery in days to a few weeks, and tend to occur during high voltage charging. Under this fault condition the ICD will not meet its nominal 3 months safety margin between ERI (elective replacement indicator) and EOL (end of life) and instead this has been reported to be as short as 24 hours.To date only 0.2% of affected devices are reported to have experienced premature battery depletion due to this mechanism. However, the failure rate as implant duration increases beyond 6 years is as yet unknown. Worldwide there have been 10 reported incidents of syncope (fainting) and 2 deaths (1 of which was in the UK) from lack of defibrillation therapy that may have been linked to lithium cluster induced short circuits.Although most devices will reach ERI due to normal battery depletion, it is not possible for centres to quickly differentiate these from the few that are affected by this failure mechanism. There is no way to predict which devices will suffer a lithium cluster induced short circuit and so it is important to detect ERI as soon as it occurs and replace the device as quickly as possible. At present, the risk of patient harm from revision surgery is generally greater than that of device failure, so prophylactic explant is not recommended. The relative risks, however, should be assessed on an individual patient basis taking account of their unique clinical circumstances. If the decision is made to replace an affected device St. Jude Medical will provide a replacement device at no cost.
  • Causa
    Manufactured by st jude medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy.
  • Acción
    1 Identify all affected devices supplied to your hospital by checking: Do not implant affected devices; quarantine them and contact St Jude Medical to arrange return.3 Identify all patients already implanted with an affected device.4 Prophylactic replacement of these devices is not recommended except in exceptional circumstances.5 Replace all implanted devices that reach ERI as quickly as possible, prioritising pacing dependent patients, as time remaining to EOL is unpredictable and may be no more than a day.6 Undertake the following steps to help ensure early ERI identification:review the most recent programmed parameter print-outs where possible to verify whether the ‘Device at ERI’ parameter under the ‘Trigger Alerts When’ section is programmed ‘ON’ for both ‘Show on FastPath’ and ‘Notify Patient’ selections follow up as soon as possible any patient for whom this is programmed ‘OFF’ or it is not possible to verify the alerts status, to ensure both parameters are programmed ‘ON’ ensure as many patients as possible are enrolled in remote monitoring with the ‘Direct Alerts’ feature enabled at the next scheduled in-clinic follow-up: evaluate battery status ensure patients can feel their vibratory alert and know to call their cardiac centre immediately if this is triggered. remind patients of the importance of using their remote monitoring7 Consider providing patients with the St Jude Medical patient advisory letter or one produced locally.


  • Modelo / Serial
  • Descripción del producto
    Models containing the affected battery design are:Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra, ICD and CRT-D.Family UK model numbers UK launch Fortify CD1233-40, CD1233-40Q, CD1235-40, CD1235-40Q, Q1 2010 Fortify CD2233-40, CD2233-40Q, CD2235-40, CD2235-40Q Q1 2010 Unify CD3235-40, CD3235-40Q, CD3251-40, CD3251-40Q Q1 2010 Assura CD3267-40, CD3267-40Q, CD3261-40, CD3261-40Q Q1 2012 Assura CD3361-40, CD3361-40C, CD3361-40Q, CD3361-40QC Q1 2012 Assura CD3367-40, CD3367-40C, CD3367-40Q, CD3367-40QC Q1 2012 Assura CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC Q1 2012 Assura CD2259-40, CD2259-40Q, CD1259-40, CD1259-40Q Q1 2012 Assura CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC Q1 2012 Assura CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC Q1 2012
  • Manufacturer


  • Dirección del fabricante
    Vicki Snow Snr Quality & Regulatory Manager, UK & Ireland St. Jude Medical UK Limited Capulet House Stratford Business and Technology Park Banbury Road Stratford-upon-Avon CV37 7GX Telephone: 01789 207 637Email:
  • 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