Events

Alerta De Seguridad para Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo II DR/VR (D284DRC, D284VRC)

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
    2010-05-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20100506.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
    Software defects cause malfunctioning in medtronic's implantable cardiac devices the department of health (dh) today (may 5) received notification from medtronic international limited (mil), the local branch of a multi-national medical device manufacturer, that software problems in six of its implantable cardiac devices may risk life-threatening though rare malfunctioning. a dh spokesman said, the affected models are consulta crt-d (d234trk), secura dr/vr (d234drg, d234vrc), maximo ii crt-d (d284trk) and maximo ii dr/vr (d284drc, d284vrc). all except maximo ii vr (d284vrc) are distributed in hong kong. as of april 19 this year, the manufacturer has received five confirmed reports of defect out of approximately 144 000 devices sold worldwide. however, it is reassuring that no patient injury or death arising from the affected devices has been reported thus far. here in hong kong, mil's record shows that a total of 40 affected devices have been implanted in patients of either hospital authority or private hospitals. mil recommends no change to current patient management. the devices will receive software updating upon the patients’ next scheduled clinic follow-up. the company is contacting physicians concerned individually. the spokesman does alert patients who have the deficient implants that if they experience cardiac symptoms or hear alerts from the devices, they should seek medical attention immediately. patients can call mil’s hotline at 2919 6413 for further details. meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with mil on further development, if any. ends/wednesday, may 5, 2010.

Device

Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo I...
  • Modelo / Serial
  • Descripción del producto
    Press release: Software Defects Cause Malfunctioning in Medtronic's Implantable Cardiac Devices
  • 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