Events

Rappel de Medtronic Synchromed II Implantable Infusion Pump

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
    14927
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • 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
    Manufacturer is undertaking a hazard alert for the following 3 issues:, internal electrical shorting - an electrical short can occur when ions from the drug solution and humidity permeate through the drug patrhway tubing inside the pump and interact with the feedthough over time. this may present as a motor stall, or low battery reset/ alarm and leads to a loss or reduction in therapy., priming bolus - patients may receive unintended drug at a high rate of infusion in the csf during the priming bolus and a period of reduced concentration of drug wll occur following the priming bolus., pump refill - this is a re-issue and update of information sent to patient in dec 2010.
  • Action
    Manufacturer to issue advice regarding use

Device

Medtronic Synchromed II Implantable Infusion Pump

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