Events

Rappel de Device Recall Medtronic MiniMed Implantable Insulin Pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic MiniMed Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68633
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2173-2014
  • Date de mise en oeuvre de l'événement
    2014-06-16
  • Date de publication de l'événement
    2014-08-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128358
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    Medtronic minimed is recalling the implantable insulin pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.
  • Action
    An Urgent Field Safety Notice Letter dated 6/16/14 was sent to all customers who purchased the Medtronic Implantable Insulin Pump. The letter informs the customers of the problems identified and the actions to be taken. Customers are informed that Medtronic MiniMed is working to make new unaffected pumps available as soon as possible. Customers are instructed to contact Elisabeth Andrieu at + 33 6 89 71 9056 or Dr. Francine Kaufman at +1 818.576.5331.

Device

Device Recall Medtronic MiniMed Implantable Insulin Pump
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    New Jersey and Worldwide: Belgium, France, Netherland, and Sweden
  • Description du dispositif
    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
  • Manufacturer
    Medtronic MiniMed Inc.

Manufacturer

Medtronic MiniMed Inc.
  • Adresse du fabricant
    Medtronic MiniMed Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • 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
    USFDA