Events

Retiro De Equipo (Recall) de Alto implantable cardioverter defibrillator

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 ela Medical Llc.

¿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
    30273
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0176-05
  • Fecha de inicio del evento
    2004-10-21
  • Fecha de publicación del evento
    2004-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35594
  • 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
    Alto implantable defibrillators models 614 and 615. these models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.
  • Acción
    The company observed occurrences of premature battery depletion and/or prolonged charge time for some Alto 614 and Alto 615 devices. The firm is requesting physician's assistance to monitor the performance of a limited number of implanted Alto 614 and 615 devices.

Device

Alto implantable cardioverter defibrillator
  • Modelo / Serial
    Model Numbers DR model 614, VR model 615
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.
  • Descripción del producto
    Alto implantable cardioverter defibrillator
  • Manufacturer
    ela Medical Llc

Manufacturer

ela Medical Llc
  • Dirección del fabricante
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA