Events

Retiro De Equipo (Recall) de Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

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 St Jude Medical CRMD.

¿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
    58686
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2733-2011
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2011-07-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99926
  • 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 Cardiac Monitor (without arrythmia detection) - Product Code MXC
  • Causa
    The recall was initiated because st. jude medical made new software available for the sjm confirm dm2100 implantable cardiac monitor (icm) that incorporates enhancements to the devices sensing algorithm. these enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. the user is presented with the option to upgrade new software into the sjm confirm icm.
  • Acción
    St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers. The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form". For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774

Device

Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)
  • Modelo / Serial
    Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
  • Descripción del producto
    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). || This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Dirección del fabricante
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA