Events

Alerte De Sécurité sur MEDTRONIC IMPLANTABLE INFUSION PUMP. Models: SYNCHROMED II 8637-20 and 8637-40; SYNCHROMED EL 8626-10, 8626L-10, 8626-18, 8626L-18; SYNCHROMED EL 8627. Anvisa Registries No. 10339190229, 10339190104 and 10339190105.

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 Medtronic Comercial 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
    1204
  • Date
    2012-11-27
  • 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
    According to Medtronic Ltd., based on data from the Medtronic Implantable Systems Performance Registry (ISPR), the overall failure rate of the SynchroMed II pump, at 78 months after implantation, is 2.4% when it is used to infuse approved drugs, and 7.0% when used to infuse non-approved drugs. The use of unapproved drugs can lead to intermittent or permanent pump motor blockages, which can be reported as a loss of or change in therapy - pumps may present motor blockages when used with approved or unapproved drugs, however, of the pump motor were reported at a significantly lower rate when only approved drugs are used (as quoted above). Additional information: Alert message published by the company at: http://portal.anvisa.gov.br/wps/wcm/connect/1a4a23004d9b08eab88ef9c116238c3b/Carta_de_Comunicacao_ao_Cliente.pdf?MOD=AJPERES. List of drugs approved for use in Synchromed pumps: http://portal.anvisa.gov.br/wps/wcm/connect/4c479d804d9b095bb897f9c116238c3b/Lista_dos_Farmacos_Aprovados.pdf?MOD=AJPERES Report on increased risk of engine crash: http: / / / / / / / #### UPDATE (03/13/2013): This field action was finalized by Medtronic Comercial Ltda on 02/02/2013 (see file 0126047 / 13-2). The company showed the sending of warning messages to customers who own the product at risk. ####
  • Cause
    Use of non-approved drugs for synchromed infusion pumps may increase the chance of intermittent or permanent motor blockage, leading to underdosing or loss of therapy.
  • Action
    The company is sending an alert message ("Urgent Safety Warning - Use of Unapproved Drugs with the Synchromed Implantable Infusion Pump), with information about the problem and ways to avoid it - not using drugs that have not been approved for the product concerned.

Device

MEDTRONIC IMPLANTABLE INFUSION PUMP. Models: SYNCHROMED II 8637-20 and 8637-40; SYNCHROMED EL 862...

Manufacturer

Medtronic Comercial Ltda.
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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