Alerta De Seguridad para Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por St Jude Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: st. jude medical implantable devices- fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra medical device manufacturer, st jude medical, has issued a medical device safety alert concerning its implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) manufactured before may 2015. the affected models are fortify, fortify assura, quadra assura, quadra assura mp, unify, unify assura and unify quadra. according to the manufacturer, among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. forty-six exhibited visible clusters bridging the cathode and anode causing shorting. lithium cluster formation is a known phenomenon with this type of battery. the manufacturer is contacting physicians to provide details regarding risk and patient management recommendations because premature battery depletion has been observed to occur within days. there have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion. high voltage devices (icds and crt-ds) that utilize lithium-based battery chemistries are subject to lithium cluster formation during high voltage charging. depending on their location, lithium clusters may cause a short circuit that can lead to premature battery depletion. the manufacturer’s investigation indicates that if a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy. premature battery depletion can be identified by physicians through home monitoring or in person visits showing elective replacement indicator (eri) or more advanced battery depletion. patients may become aware when their device reaches eri because they may feel a vibratory patient notifier alert. patients who cannot feel the vibratory alert may not know their device has reached eri. therefore, the manufacturer has provided recommendations below that include confirming patients can feel and recognize vibratory alerts and reaffirming the availability and usage of home monitoring to avoid or minimize time without device therapy for bradycardia and tachycardia events. the manufacturer provided physicians with the following patient management recommendations: do not implant unused affected devices. conduct patient follow-up per standard practice. prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion due to lithium cluster induced shorts. in the event of an eri indicator in these devices, immediate device change is recommended. at this time there is no factor, method or test to identify devices with this form of premature battery depletion approaching eri or to accurately predict remaining battery life once eri appears. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for further patient management recommendations and other necessary actions. posted on 11 october 2016.


  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Medical Device Safety Alert: St. Jude Medical Implantable devices- Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra
  • Manufacturer


  • 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