Alerta De Seguridad para Implantable Defibrillator (Photon DR V-230), Registry 10332340083; Implantable Defibrillator (Photon DR V-232), Register 10332340090 Implantable Defibrillator (Photon VR V-194), Registry 10332340092, Implantable Cardioverter Defibrillator (Atlas DR V-240 V-199), Register 10332340093.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por St. Jude Medical Brasil.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    ANVISA through the Technovigilance Unit will monitor all relevant actions. If you have any questions, please contact St. Jude Medical Brazil at (11) 5080-5400, and for event notification associated with the use of the equipment, contact ANVISA - Technovigilance Unit by telephoning 61 - 3448 1485 or by
  • Causa
    The company st. jude medical has detected a low frequency related to a specific supplier's static random access memory chip used in the following st. jude medical cardiac defibrillators: photon dr (model v-230hv) (certain serial numbers); photon micro vr / dr (models v-194 / v-232); atlas vr / dr (models v-199 / v-240). this anomaly may cause a temporary loss of the stimulation function and permanent loss of the defibrillation support. this occurred because the said memory chip could be affected by the cosmic background radiation that reaches the earth. it is common knowledge that cosmic background radiation constantly bombards the earth. while the earth's atmosphere acts as a shield and absorbs much of this cosmic radiation, some amount of high energy particles hits the earth. st. jude medical has determined that when the static access memory (sram) chip is exposed to background levels of atmospheric ionizing cosmic radiation it can cause a high current drain state, causing the problem described above. according to the company, in brazil, 1028 of these devices were implanted.
  • Acción
    The company forwarded to the doctors responsible for the implantation of these devices in Brazil a letter alerting them to the problem and with instructions on how to proceed, as follows: • "If it is not already part of your current practice, doctors should routinely monitor the device every 3 months for patients with the affected models listed above. "•" In determining whether additional follow-up will be necessary, consider the low failure rate of the anomaly and the unique and individual needs and medical situations of each patient , including whether the patient is pacemaker dependent or is at high risk of life due to arrhythmias. "•" If a patient's device is detected as in Hardware Reser Mode, you should arrange for replacement of the patient as soon as possible. "•" Continue to provide patients with the usual warnings so they do not miss scheduled appointments and report any changes in symptoms. "


  • Source