Retiro De Equipo (Recall) de Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs) Affected devices implanted in Australia:Evera XT VR ICD

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    An issue has been identified with certain devices that were manufactured with a specific subset of circuit components. devices in the affected population may experience rapid battery depletion due to a low resistance path developing within the circuit component. development of a low resistance path in the circuit component in some cases has been reported to cause battery depletion in seven (7) days or less and may present clinically during a patient follow-up visit as:- one or more electrical resets, which will display as an observation on the programmer.- no pacing or defibrillation therapy output.- no telemetry.- programmer screen display of serious device memory failure.Patient audible alerts and carealerts may not reliably notify the patient or clinician. within these 78 devices there have been seven (7) confirmed failures (9%) through july 16, 2016. reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
  • Acción
    Physicians are asked to advise patients to seek medical attention immediately if they experience symptoms (e.g., fainting or light-headedness) or if the audible patient alert sounds. For pacemaker-dependent patients or those at a higher risk of Ventricular Tachycardia or Ventricular Fibrillation, Physicians should consider device replacement. For other patients, Medtronic is recommending: · Program the audible alerts for “Low Battery Voltage RRT” to “On-High”. It is possible that alerts may not sound if the battery is depleted. Therefore physicians should also consider one of the following: - Provide a handheld magnet to patients to frequently check device status. - Prescribe either a CareLink transmission be performed by the patient, or a maintenance transmission by the clinic, on a more frequent basis (e.g., weekly or daily) based on the unique patient considerations. Medtronic is offering the above additional options at no cost.


  • Modelo / Serial
    Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs)Affected devices implanted in Australia:Evera XT VR ICD Model: DVBB2D4Serial numbers: BWJ601108S, BWJ601112S, BWJ601479S ARTG number: 208027
  • Clasificación del producto
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source