Events

Alerte De Sécurité sur Implantable Defibrillator Software:. EPIC HF V-339. EPIC + V-196. EPIC + V-236. EPIC + HF V-350. ATLAS + V-193. ATLAS + V-243. ATLAS + HF V-341. ATLAS + II V-268

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par St. Jude Medical Brasil Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    900
  • Date
    2008-01-28
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Since July 2002 around 143,000 CDIS of the EPIC and ATLAS families have been implemented around the world, and around 123000 remain active today. To date, eight devices (among the 143,000) that have lost ventricular sensing have been detected - the risks detrimental to the patient are in the order of 1 in 1 million. The loss of ventricular sensing was attributed to a well-defined but extremely rare timing sequence that occurs in a very short time window (61 microseconds). To date, there have been no reports of injury or death of any patient to St Jude Medical because of the problem cited. According to St. Jude Medical Ltda, a simple software updater of the generator programmer / firmware will solve the problem, being possible, according to information presented by the company, the software update of both implanted equipment and those not yet implemented . For more details, consult the informative letter provided by St. Jude Medical Ltda (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta900_carta.pdf). The Anvisa Technovigilance Unit is following up on this case. ## Update (09/03/2009): St. Jude Medical Brasil Ltda informed the UTVIG / Anvisa on 03/12/2008 about the completion of the updating process of the mentioned defibrillators this alert.
  • Cause
    Possibility of loss of ventricular sensing in the implantable cardioverter defibrillators (dcis) of the epic and atlas families.
  • Action
    The company that registers the EPIC and ATLAS cardioverters in Brazil, ST JUDE MEDICAL BRASIL LTDA, started in Brazil an update of the software integrating implantable cardioverter defibrillators (CDIS). Sales teams and clinical field engineers at St. Jude Medical will carry out the software upgrade on the already distributed PCS Merlin and Model 3510 programmers.

Device

Implantable Defibrillator Software:. EPIC HF V-339. EPIC + V-196. EPIC + V-236. EPIC + HF V-350. ...

Manufacturer

St. Jude Medical Brasil Ltda.
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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