Events

Alerta De Seguridad para Concerto CRT-D and Virtuoso ICD

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic International 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
    2009-09-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20090909.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
    Heartbeat regulating products with low-voltage problem 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). a dh spokesman said, the notification from medtronic international limited involved the products, a subset of concerto crt-d and a subset of virtuoso icd. 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 230 of approximately 6,300 devices overseas have been confirmed to have accelerated battery depletion. according to the company, there have not been any report ed deaths or serious injuries resulting from the problem, both overseas and locally. according to the medtronic international limited, in hong kong , three devices have been implanted in hospitals under hospital authority (ha). medtronic has contacted ha and related doctors to advise them how to address the problem . the spokesman said, individual patients implanted with affected devices should follow their scheduled appointments for follow up. however, they should contact their attending doctors immediately if receive an alert tone coming from their implanted device . patients may call medtronic international limited's hotline at 2919 6413 for further details about the notification . the dh has informed public and private hospitals, and medical professional associations about this notification and advise d them to take necessary follow up actions. ends/tuesday, september 8, 2009.

Device

Concerto CRT-D and Virtuoso ICD
  • Modelo / Serial
  • Descripción del producto
    Press release: Heartbeat Regulating Products with Low-voltage Problem
  • Manufacturer
    Medtronic International Limited

Manufacturer

Medtronic International Limited
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH