Events

Safety Alert for The Field Action affects five products registered in Brazil. FORTIFY ™ - Registration 10332340305. UNIFY - Registration 10332340299. Fortify Assura VR - Registration 10332340358. Unify Assura - Registration 10332340344. Implantable Cardioverter and Defibrillator Quadra Assura - Record 10332340343

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

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
    2010
  • Date
    2016-10-24
  • 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
    In collaboration with the Medical Advisory Committee of St. Jude Medical, the company recommends:  Do not implant affected unused devices.  Perform routine follow-up of patients according to standard practice.  We have included a "Patient Notification Letter" attached to this letter, so you can provide your patients with information to help them with this event.  Prophylactic replacement of the device is NOT recommended because the rates of device replacement complications are greater than the risk rate associated with premature battery depletion due to the short lithium deposits induced (see appendix for selected references ).  In the case of an ERI indicator on these devices, it is recommended that they be replaced immediately. At this time, there is no factor, method, or test to identify devices with this form of premature battery depletion near the ERI or to accurately predict the remaining battery life once the ERI appears.  Physicians should reaffirm the availability of remote monitoring to avoid or minimize time without device therapy for bradycardia and tachycardia events.  Enroll patients on the Merlin.net system using the "Direct Alerts" feature to receive immediate alert notification if the ERI is reached. For patients currently enrolled in Merlin.net, remind them of the importance of using remote monitoring.  Review the most recent printing of the programmed parameters (see annex with an example).  Make sure that in the "Trigger Alerts When" section that the "Device at ERI" parameter is set to "ON" (the nominal is "ON") for both "Show on FastPath" and "Notify Patient" options. "Device at ERI" is set to OFF, it is recommended that the patient is promptly seen to program this parameter to ON  Inform patients that an exchange prompt (ERI) triggers a vibrating alert. the patient's device to determine if an ERI alert has been triggered.Perature premature battery depletion can be identified by remote monitoring showing ERI or advanced battery drainage  Perform a test on the patient's vibratory notifier to confirm that it can feel, and acknowledge this alert  Patients who can not feel the vibrating alert may not know that your device has run out of battery and / or function capacity  Advise the patient to enter contact your clinic immediately if they feel the vibrating alert  Face-to-face assessment should be performed to determine the reason for the alert, as other non-critical events can also trigger a vibrating alert.
  • Reason
    High voltage devices (icds and trc-ds) that use lithium-based chemical batteries are subject to the formation of lithium deposits during high voltage charging. depending on your location, lithium deposits may cause a short circuit that could lead to premature battery drainage.
  • Action
    Field Action Code CDI's triggered under the responsibility of the company St. Jude Medical Brasil LTDA. Company issued Safety Alert informing about possible premature battery depletion associated with CDI if CDI s St. Jude Medical Brazil Resyncers manufactured before May 2015.

Device

The Field Action affects five products registered in Brazil. FORTIFY ™ - Registration 10332340305...

Manufacturer

St. Jude Medical Brasil LTDA; St. Jude Medical
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA