Retiro De Equipo (Recall) de Device Recall VITALITY DR HE

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
    37769
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1054-2007
  • Fecha de inicio del evento
    2007-03-23
  • Fecha de publicación del evento
    2007-07-11
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2008-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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 defibrillator - Product Code NIK
  • Causa
    Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
  • Acción
    An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.

Device

  • Modelo / Serial
    Model T180, serial numbers: 200020, 200025, 200029, 200059, 200063, 200065, 200068, 200088, 200109, 200111, 200210, 200237, 200358, 200360, 200362, 200440, 200443, 200480, 200581, 200584, 200627, 200663, 200700, 200717, 200725, 200727, 200730, 200743, 200774, 200801, 200847, 200863, 200868, 200884, 200916, 200918, 200962, 200979, 201013, 201026, 201064, 201077, 201082, 201108, 201115, 201124, 201138, 201149, 201151, 201166, 201171, 201182, 201186, 201222, 201224, 201227, 201243, 201263, 201281, 201283, 201287, 201290, 201297, 201298, 201308, 201332, 201388, 201393, 201396, 201451, 201479, 201481, 201524, 201530, 201539, 201548, 201550, 201582, 201589, 201592, 201617, 201629, 201634, 201649, 201685, 201700, 201701, 201702, 201704, 201731, 201732, 201759, 201763, 201768, 201838, 201841, 201861, 201872, 201874, 201891, 201901, 201905, 201908, 201909, 201927, 201929, 201930, 201931, 201933, 201934, 201936, 201937, 201938, 201939, 201940, 201941, 201942, 201943, 201944, 201945, 201946, 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  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.
  • Descripción del producto
    VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing).
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA