Events

Retiro De Equipo (Recall) de Device Recall Guidant VITALITY AVT ICD

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
    44793
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0048-2008
  • Fecha de inicio del evento
    2007-03-16
  • Fecha de publicación del evento
    2007-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64389
  • 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 - Product Code LWP
  • Causa
    Erroneous display/atypical charge time behavior: 1)-end of life (eol) or eri is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- extended eri charge time limits: charge times during mid-life may remain below a normal extension of the eri charge time . ****** prophylactic replacement of these devices prior to eri is not recommended. as stated.
  • Acción
    A Product Update titled "ERI Charge Time Limit Extended During Mid-Life and Mid-Life Display of Replacement Indicators", dated 03/10/2007 was posted to Company's website on 03/13/2007. A CRM Product News letter was sent to physicians beginning 03/16/2007. The CRM Product News Letter gave an overview of the content of the Product Update and stated the web location for finding the complete Product Update. The Product Update identified affected devices, gave an overview of normal charge time behavior at mid-life for specific ICD and CRT-D devices. The letter also described the atypical charge time behavior, projected rate of mid-life display of replacement indicators and Patient Management Considerations. ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product Update, "Devices that have triggered charge time-based ERI or EOL during mid-life have several months, and in most cases more than one year of remaining battery voltage and capacity, which allows the devices in this pattern to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is triggered, device replacement should be scheduled."*****Recalled units only cover devices implanted prior to July 2005****

Device

Device Recall Guidant VITALITY AVT ICD
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide
  • Descripción del producto
    Guidant VITALITY AVT, Models A135 and A155. Implantable Cardioverter Defibrillator, ICD. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
  • 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