Events

Rappel de Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Programmers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty 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
    RC-2014-RN-00288-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-12
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00288-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Post market review by medtronic has identified that there is the potential for patients to experience spinal cord compression weeks to years after implant of a spinal cord stimulation lead. spinal cord compression can lead to neurological deficit due to the formation of reactive tissue, sometimes with an inflammatory component. the time to onset for spinal cord compression ranges from weeks to over 17 years, and may progress after lead removal.
  • Action
    Medtronic is advising surgeons that prophylactic removal of the leads is not recommended. Awareness of this adverse event can lead to early detection and prevention of permanent neurological impairment. If a patient presents with new neurological deficit, spinal cord compression due to reactive tissue mass formation should be considered as a potential cause. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-spinal-cord-140317.htm .

Device

Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Program...
  • Modèle / numéro de série
    Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient ProgrammersMultiple model numbers affectedARTG Numbers: 141860, 154866, 141861, 177594, 215751, 215748, 215749, 215750, 143034, 141857, 137079, 123240, 123242, 137080, 123241, 123243, 214838, 214839, 137348, 143035, 141858, 114947, 119320, 163895, 148397, 219258, 219259, 134080, 137439, 139649, 177036 and 214421
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA