Events

Alerta De Seguridad para SonRtip endocardial pacing lead with contractility sensor, model PS55D

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

¿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
    2012-02-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120228b.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
    Medical Device Safety Alert
  • Causa
    Field safety notice: sonrtip endocardial pacing lead with contractility sensor, model ps55d the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning sonrtip endocardial pacing lead with contractility sensor, model ps55d. the manufacturer of the device, sorin crm, has received two reports in post-market surveillance that part or all of the fixation helix of the sonrtip lead remained in the myocardium after the lead had been removed. no permanent injury or death has occurred. investigation by the manufacturer revealed that an excessive number of turns has been applied to the lead during fixation. according to the local supplier, the affected product is not distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

SonRtip endocardial pacing lead with contractility sensor, model PS55D
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SonRtip endocardial pacing lead with contractility sensor, model PS55D
  • Manufacturer
    Sorin CRM

Manufacturer

Sorin CRM