Events

Safety Alert for IMPLANTABLE CARDIOVERSOR DEFIBRILLATOR ENTRUST. Registration Anvisa n ° 10339190257 (registration expired on 11/14/2010 and not renewed).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA..

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
    1121
  • Date
    2012-03-27
  • 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
    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).
  • Reason
    Premature battery drainage.
  • Action
    Treatment recommendations: Physicians should keep routine follow-up sessions at least every three months in accordance with the instructions for use of the product. Patient alerts must also be programmed for "Low Battery Voltage ERI" and "Excessive Charge Time EOL" to ON and immediately replace devices after reaching ERI if the voltage reduction is faster than expected. Entity Proactive / Proactive Replacements are not recommended.

Device

IMPLANTABLE CARDIOVERSOR DEFIBRILLATOR ENTRUST. Registration Anvisa n ° 10339190257 (registration...

Manufacturer

MEDTRONIC COMERCIAL LTDA.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA