Events

Retiro De Equipo (Recall) de Device Recall CONTAK RENEWAL 2 CRTDefibrillator

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 Guidant 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
    32380
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0908-05
  • Fecha de inicio del evento
    2005-06-17
  • Fecha de publicación del evento
    2005-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40302
  • 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
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
  • Causa
    Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.
  • Acción
    Dear Doctor letter was dated and issued 06/17/05 informing Doctors of an shorting issue of the Renewal 1 & 2 CRT-D devices. The letter gave indications of device failure and recommendations for patient visits. A press release was also issued on 06/17/05.

Device

Device Recall CONTAK RENEWAL 2 CRTDefibrillator
  • Modelo / Serial
    RENEWAL 2 (model H155) serial number range 173277 - 777182 includes CRT-Ds manufactured on or before August 26, 2004.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom and Venezuela.
  • Descripción del producto
    CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
    Guidant Corporation

Manufacturer

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