Events

Alerta De Seguridad para PULSAR MAX, PULSAR, DISCOVERY, MERIDIAN , PULSAR MAX II, DISCOVERY II, VIRTUS PLUS II, INTELIS II and CONTAK TR pacemakers

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

¿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
    2005-07-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20050719.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
    Corrective action of guidant implantable cardiac pacemakers 19 july 2005 the department of health has been notified by the guidant corporation of an “urgent medical device safety information and corrective action” concerning some of their implanted cardiac pacemakers. the pacemakers in question may experience premature battery depletion without warning, inappropriate pacing and early display of replacement indicators. the affected pacemakers are pulsar max, pulsar, discovery, meridian , pulsar max ii, discovery ii, virtus plus ii, intelis ii and contak tr pacemakers manufactured between 25 november, 1997 and 26 october, 2000. if these devices exhibit the above failure mode, patients may notice prolonged rapid heart beating and develop dizziness. in serious circumstances, though uncommon, they may develop heart failure symptoms such as shortness of breath and loss of consciousness. the manufacturer has sent letters to doctors with patients implanted with the pacemakers to alert them of the incident, and advise replacement of the pacemakers where necessary. affected patients are urged to contact their doctors for advice. guidant hong kong limited has set up two hot lines 2593 2210 and 6292 2308 for public enquiry during office hours. the department of health has alerted the hospital authority, private hospitals and medical associations of the corrective action undertaken by guidant on some of their cardiac pacemakers.

Device

PULSAR MAX, PULSAR, DISCOVERY, MERIDIAN , PULSAR MAX II, DISCOVERY II, VIRTUS PLUS II, INTELIS II...
  • Modelo / Serial
  • Descripción del producto
    Press release: Corrective Action of Guidant implantable cardiac pacemakers
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • 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.”
  • Source
    DH