Events

Retiro De Equipo (Recall) de INSIGNIA Ultra and NEXUS Ultra

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
    33491
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0188-06
  • Fecha de inicio del evento
    2005-09-22
  • Fecha de publicación del evento
    2005-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42405
  • 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 Pacemaker Pulse-Generator - Product Code DXY
  • Causa
    A failure mode occurring at a low rate, has been identified within the insignia and nexus families of implantable pacemakers. device behaviors which may be observed include: intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
  • Acción
    Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.

Device

INSIGNIA Ultra and NEXUS Ultra
  • Modelo / Serial
    INSIGNIA Ultra SR (model 1190) serial no. 889963 - 891468; NEXUS Ultra SR (model 1390) serial no. 100007 - 100034. INSIGNIA Ultra DR (model 1290) serial no. 100678 - 105229; (model 1291) serial no. 100279 - 100913; NEXUS Ultra DR (model 1490) serial no. 100007, 100008, 100009, 100013, 100014, 100015, 100016, 100017, 100018; (model 1491) serial no. 100007, 100008, 100009, 100010, 100013, 100015, 100016, 100017, 100018.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Polynesia, Portugal, Qatar, Reunion, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela
  • Descripción del producto
    Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. || Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Dirección del fabricante
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA