Events

Alerte De Sécurité sur Deep Brain Stimulation (DBS) system

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medtronic Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-05-16
  • Date de publication de l'événement
    2016-05-16
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160516.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: medtronic deep brain stimulation (dbs) system medical device manufacturer, medtronic ltd, has issued a medical device safety alert concerning its deep brain stimulation (dbs) system. the safety alert relates to two separate issues: loss of coordination and the tunneling procedure of the dbs system. issue one - loss of coordination this issue relates to activa rc (37612), activa pc (37601), activa sc (37602 and 37603), activa pc+s (37604), kinetra (7428) and soletra (7426). the manufacturer has become aware of a reported event of inability to swim following dbs implantation and initiation of dbs therapy for parkinson’s disease in a patient who was an experienced swimmer. while the issue was identified in a patient being treated for parkinson’s disease (a movement disorder), it may apply to any approved dbs therapy indication. patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after dbs therapy is first turned on and after programming changes until any effects of their dbs therapy on coordination are understood. issue two - tunneling procedure this issue relates to dbs extensions models 7483 and 37086, tunneling tools 3755, 3550-05. the manufacturer’s post marketing surveillance for dbs therapy has identified the following serious events or injuries associated with tunneling that are not presented in the current dbs labeling. the following events are associated with the dbs implant and tunneling the extension from the lead to the implantable neurostimulator (ins): cases of spinal accessory nerve injury severe bleeding or vascular injury an extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision tunneling too superficially resulting in an extension that exited and then re-entered the neck which was not discovered until the surgical drape was removed. these events occurred in an estimated 0.008% of tunneling procedures. the manufacturer advises that during the dbs implant, users should be cautious while tunneling the extension from the lead to the ins to avoid tunneling too deeply or superficially because serious injury may occur. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 may 2016.

Device

Deep Brain Stimulation (DBS) system
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Deep Brain Stimulation (DBS) system
  • Manufacturer
    Medtronic Ltd

Manufacturer

Medtronic 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
    DH