Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by St. Jude Medical Brasil.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    817
  • Date
    2005-10-25
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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 tecnovigilancia@anvisa.gov.br.
  • Reason
    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.
  • Action
    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. "

Device

Implantable Defibrillator (Photon DR V-230), Registry 10332340083; Implantable Defibrillator (Pho...

Manufacturer

St. Jude Medical Brasil
  • Source
    ANVSANVISA