Events

Alerte De Sécurité sur InterStim, InterStim II, Itrel 3 and Enterra

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.

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
    2015-01-13
  • Date de publication de l'événement
    2015-01-13
  • 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_20150113.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 neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation medical device manufacturer, medtronic, inc., has issued a medical device correction notice concerning interstim, interstim ii, itrel 3 and enterra devices. the manufacturer is updating the labeling related to the cycling feature in the above neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation. current labeling indicates the use of cycling improves device longevity under every programming scenario; however, enabling cycling at certain parameter settings may decrease the device battery longevity. furthermore, when cycling is enabled, longevity estimation displayed on the n’vision clinician programmer (model 8840) may not be accurate. the potential hazard would be premature battery depletion requiring an earlier than anticipated device replacement. there is no impact from this issue to therapy delivered or battery level notifications. according to the local supplier, 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 13 january 2015.

Device

InterStim, InterStim II, Itrel 3 and Enterra
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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