Events

Retiro De Equipo (Recall) de Device Recall LATITUDE Patient Management System Communicator

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 CRM Corp.

¿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
    61107
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1135-2012
  • Fecha de inicio del evento
    2012-01-19
  • Fecha de publicación del evento
    2012-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107311
  • 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
    One (1) model 6476 latitude communicator is unable to interrogate the patient's pulse generator. boston scientific has determined that this is due to a patient receiving an incorrect communicator. therefore the communicator did not find and was unable to interrogate the assigned patients pg. additionally when the patient attempted to set-up this incorrect communicator, the system reflected.
  • Acción
    On January 19, 2012 Boston Scientific telephoned the affected patient and their clinic. The patient was notified that the communicator they received will not be able to activate successfully and that their communicator and sensors would be replaced. The clinician was informed of the patient's communicator was sent incorrectly to the other patient who attempted to activate it, the monitored status of the website was incorrect and that a new communicator would be shipped to the patient that will work with their device.

Device

Device Recall LATITUDE Patient Management System Communicator
  • Modelo / Serial
    SN 224453
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: UT only.
  • Descripción del producto
    Boston Scientific, LATITUDE¿ Patient Management System Communicator, Models 6476. || The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

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