Events

Retiro De Equipo (Recall) de RESONATE EL ICD VR

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 Boston Scientific Corporation.

¿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
    78323
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0077-2018
  • Fecha de inicio del evento
    2017-10-04
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159184
  • 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
    The devices have an incorrect firmware configuration.
  • Acción
    The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.

Device

RESONATE EL ICD VR
  • Modelo / Serial
    Serial numbers 224020, 224209, 224322, 224366, and 224506
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
  • Descripción del producto
    RESONATE EL ICD VR, Model D432, Sterile.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • 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
    USFDA