Alerta De Seguridad para IMPLANTABLE CARDIOVERSOR DEFIBRILLATOR ENTRUST. Registration Anvisa n ° 10339190257 (registration expired on 11/14/2010 and not renewed).

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.

According to the company, a portion of EnTrust Implantable Cardioverter Defibrillators (CDI's) may not meet the expected longevity or provide at least three months of device operation between the Elective Replacement Indications (ERI) and their lifetime (EOL ), due to a faster than expected fall in battery voltage. The company has not received reports of patient death or serious injury as a result of this problem. The events reported refer to a drop in battery voltage from ~ 3.0 V to ERI (2.61 V) over a period of time ranging from approximately one week to six months. All events reported occurred at least 30 months after the implant. Medtronic has confirmed nine reports of time-out of the load circuit during automatic capacitor rebuilding and a report of loss of pacing, all occurring between the ERI and the explant moment. Although there is a potential risk of high voltage loss between ERI and the explant of the device, such fact has not been reported to date according to the company. Medtronic has identified the cause of these occurrences as being a short internal battery, which occurs as the battery capacity is consumed. #### Update (08/17/2012): The record holder finalized risk communication to users of the product, as reported to UTVIG (Exp .: 0441135 / 12-8).