Events

Alerta De Seguridad para Accent DR and Anthem CRT-P

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
    2011-09-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20110926.html
  • 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
    Safety alert on two st jude medical's pacemakers - accent dr and anthem crt-p after assessment on a field safety note filed by an american medical device manufacturer, st jude medical, on safety concerns on two of its pacemakers, accent dr and anthem crt-p, respectively, the department of health (dh) today (september 23) cautions medical practitioners, especially cardiologists, about the message and also advises that affected patients should consult their attending physicians. the fault involves invalid low lead impedance measurements. a dh spokesman assists with explanation on the technical background, "the lead impedance value is an indicator to reflect the condition of the lead circuit that connects the pacemaker to the heart. in those pacemakers which have been programmed to switch polarity, an out of range reading may cause them to switch the lead polarity to unipolar. however, it is reassuring that both the pacing and sensing functions of such devices will not be affected, although sometimes clients can hear audible notifiers, or the mishap may present itself at the next clinic follow-up as varying values recorded in lead impedance trend graphs." st jude medical's records indicated that the pacemakers were initially marketed in july 2009 and hong kong has been importing them since september that year. "amongst the stock, 16 pieces of accent dr model pm2212 and 13 pieces of anthem crt-p model pm3212 are known to be involved in the present incident. although the rates of occurrence of the defects are low, 0.01% for accent dr and 1.6% for anthem crt-p, and thus far, there has not been notification of related adverse event either here or overseas, we are given to understand that the manufacturer's local representative in hong kong will get in touch with individual responsible physicians for necessary corrective actions as soon as possible," the spokesman remarks. "to ensure readings will be accurate, a new version of the programme software will be loaded onto programmers for the pacemakers," the spokesman reveals. a dh spokesman also comments that, “though the manufacturer will reach out to their clients via doctors, possible implantation of defective devices in international travellers passing through hong kong makes we think that it will only be prudent for dh to bring the news to our community for individual's necessary action.” the manufacturer has set up a hotline (9682 0488) for related enquiries and dh will be monitoring the progress of the corrective action.

Device

Accent DR and Anthem CRT-P
  • Modelo / Serial
  • Descripción del producto
    Press release: Safety Alert on Two St Jude Medical's Pacemakers - Accent DR and Anthem CRT-P
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • 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
    DH