Events

Rappel de Medtronic Amplia CRT-D Surescan

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Medtronic 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
    20927
  • Date de mise en oeuvre de l'événement
    2016-12-08
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Cause
    Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.
  • Action
    Software to be upgraded

Device

Medtronic Amplia CRT-D Surescan
  • Modèle / numéro de série
    Model: DTMB2D4, Affected:
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • 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
    NZMMDSA