Events

Rappel de N'VISION APPLICATION CARD

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA LTD..

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
    136010
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-26
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    The medical device correction includes the distribution of a new 8870 software application card version bbr/01 (revision b) which provides updates to the 8840 clinician programmer used to program medtronic spinal cord stimulators deep brain stimulators and the synchromedr ii implantable infusion system. for scs and dbs therapy: the new software provides an automatic transfer of new internal device software from the 8840 to implantable and implanted devices. this change addresses loss of stimulation caused by the exception bit behavior. this behavior is also known as error code 509. in addition the notification provides information about the potential for over stimulation or stimulation in the wrong area under a specific set of conditions typically related to device recovery from an over discharge. for synchromed ii pump therapy: the update includes correction of the issue previously communicated in the march 2012 medical device correction regarding the potential for the model 8840 n'vision clinician programmer to display an erroneous replace by date (erbd) "schedule to replace pump by" (date when used with the synchromed ii pump. the updated software also corrects the potential for premature low and empty reservoir alarms with the synchromed ii pump. these premature alarms are due to an incorrect calculation within the 8840 programmer software. no changes are being made to the implantable synchromedr ii pump device as a result of this update.

Device

N'VISION APPLICATION CARD
  • Modèle / numéro de série
    Model Catalog: 8870 (Lot serial: Not Applicable)
  • Description du dispositif
    N'VISION APPLICATION CARD
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • 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
    HC