Events

Rappel de ENTRUST SINGLE CHMBR IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.

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
    42873
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-03-07
  • 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 purpose of this action is inform physicians who have implanted or follow patients implanted with entrust icds that a small percentage of those devices may not meet expected longevity or provide at least three months of device operation between the elective replacement indicator (eri) and end of life (eol) due to a more-rapid-than-expected drop in battery voltage. medtronic also provides following patient management recommendations: o physicians should continue routine follow-up sessions at least every three months in accordance with product labelling . o physicians should program the audible patient alerts for "low battery voltage eri" and "excessive charge time eol" to on. o physicians should replace devices promptly after they reach eri if the decline in voltage is more rapid than expected. o prophylactic replacement of entrust icds is not recommended.

Device

ENTRUST SINGLE CHMBR IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.
  • Modèle / numéro de série
    Model Catalog: D153VRC (Lot serial: All Lots); Model Catalog: D154ATG (Lot serial: All Lots); Model Catalog: D153ATG (Lot serial: All Lots); Model Catalog: D154VRC (Lot serial: All Lots); Model Catalog: D154DRG (Lot serial: All Lots); Model Catalog: D153DRG (Lot serial: All Lots)
  • Description du dispositif
    ENTRUST SINGLE CHMBR IMPL. CARDIO. DEFI. W/VENTR. THER. & RAPIDR. TELEM.
  • 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