Events

Avis De Sécurité sur model 8870 software card used with the n'vision medical programmer model 8840devices for wireless control of synchromed drug infusion systems, devices for deep brain neurostimulation (dbs), marrow neurostimulation (scs) and laneurostimulation peripheral (pns).

Selon Ministero della Salute (Health Ministry), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Italy qui a été fabriqué par MEDTRONIC.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    2590
  • Date
    2013-10-01
  • Pays de l'événement
    Italy
  • Source de l'événement
    MSHM
  • URL de la source de l'événement
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=2590
  • Notes / Alertes
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 Italy.
  • Notes supplémentaires dans les données
  • Action
    updating the software card. follow the recommendations indicated nell'fsn.

Device

model 8870 software card used with the n'vision medical programmer model 8840devices for wire...
  • Modèle / numéro de série
  • Description du dispositif
    aimd
  • Manufacturer
    MEDTRONIC

Manufacturer

MEDTRONIC
  • 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
    MSHM