Retiro De Equipo (Recall) de Deikos

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biotronik Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    28982
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0944-04
  • Fecha de inicio del evento
    2004-04-29
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2006-04-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Causa
    Potential for device to not deliver full amount of energy.
  • Acción
    On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.

Device

  • Modelo / Serial
    Model Number 334 341 Serial numbers: 78062958, 78062960, 78062961, 78062962, 78062997, 78063002
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
  • Descripción del producto
    Deikos A+
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Biotronik Inc, 6024 Jean Rd, Lake Oswego OR 97035-5308
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA