Events

Rappel de SYNCHROMED II - PROGRAMMABLE PUMP

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
    28375
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2017-04-27
  • 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
    This notice provides an update to information previously communicated to physicians in july 2011 regarding the failure rate for reduced battery performance in medtronic model 8637 synchromed ii pumps manufactured through june 2011. this notice reinforces previously communicated patient management recommendations related to this issue. this notification does not apply to synchromed ii devices currently being marketed or implanted or to any previously implanted devices manufactured after june 2011. medtronic previously issued a notification regarding the potential for sudden loss of therapy due to reduced battery performance from the formation of a resistive film in a small percentage of synchromed ii pumps with batteries manufactured prior to july 2011. performance monitoring of the affected pump population has since found a higher-than-predicted failure rate in a subset of affected pumps manufactured between january 2011 and june 2011.

Device

SYNCHROMED II - PROGRAMMABLE PUMP

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