Events

Rappel de Device Recall N'Vision software Application Card

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 Neuromodulation.

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
    54477
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1214-2010
  • Date de mise en oeuvre de l'événement
    2009-03-23
  • Date de publication de l'événement
    2010-03-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88556
  • 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, implanted, programmable - Product Code LKK
  • Cause
    Routine monitoring of medtronic's vigilance program identified user related programming errors. medtronic has received reports of both overdose and underdose that were the result of programming use of synchromed implantable infusion pumps. these errors were most commonly associated with: --priming bolus programming; and --bridge bolus programming. pump programming errors that result in overdos.
  • Action
    Medtronic is exchanging 8870 versions AAG, AAJ and BBG and replacing it with the updated versions AAH01 and BBH01. The updated versions contain user interface improvements to reduce the chance of user related programming errors when programming SynchroMed II and SynchroMed EL Infusion Pump system. A Medtronic "Medical Device Correction" letter was left behind for consignees. The letter was addressed to "Healthcare Provider" and was dated February 2009. The letter provided information regarding changes to the programming software used in SynchorMed Infusion System. For additional information, please contact your Medtronic Representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Device Recall N'Vision software Application Card
  • Modèle / numéro de série
    All model 8870 application cards version AAG, AAJ (English only US & Japan) & BBG (Multi-Language OUS)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    All States in the US including DC. OUS: Austria Belgium Croatia Cyprus Czech Republic Denmark Estonia Faroe Islands Finland France French Polynesia Germany Greece Hungary India Ireland Israel Italy Kuwait Lebanon Malta Martinique Netherlands New Caledonia Norway Poland Portugal Reunion Russian Federation San Marino Saudi Arabia South Africa Spain Sweden Switzerland Turkey United Kingdom Vatican City State Canada Mexico Brasil
  • Description du dispositif
    Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Adresse du fabricant
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 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