Alerta De Seguridad para 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

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.

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.