Alerta De Seguridad para CONTAK RENEWAL 3 & 4 families of CRT-Ds, VITALITY and VITALITY 2 families of ICDs

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

¿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
  • 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
    Press release
  • Causa
    Advisory notice on use of heartbeat regulating products the department of health (dh) received notification from a medical device manufacturing company about possible battery life-related problem of certain devices used for regulating heartbeats, including implantable cardiac defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds). the notification from boston scientific hong kong limited involved the following products – a subset of contak renewal 3 & 4 families of crt-ds and a subset of the vitality and vitality 2 families of icds. it was found that the problem is due to a low-voltage capacitor which may be subject to degradation, causing accelerated depletion of the batteries in the affected products. so far 19 of approximately 73,000 devices overseas have been confirmed to have accelerated battery depletion. according to the company, there have not been any reported deaths or serious injuries resulting from the problem, both overseas and locally. according to the boston scientific hong kong limited, in hong kong , 15 devices have been implanted in hospitals under hospital authority (ha) and three in private hospitals. boston scientific has contacted ha and related doctors to advise them to follow up with patients in their clinics as soon as possible. individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. patients may call boston scientific hong kong limited's hotline at 2960 7128 or visit boston scientific's website at http://www.Guidant.Com/ppr/advis/2007_04_05.Shtml for further details about the notification. the dh has informed public and private hospitals, and medical professional associations about this notification and advised them to take necessary follow up actions. ends friday, april 13, 2007.



  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
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