Events

Alerte De Sécurité sur Intrathecal catheter Ascenda

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Medtronic Neuromodulatiòn.

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
  • ID de l'événement
    I1408-318
  • Numéro de l'événement
    2011DM-0008132
  • Date
    2014-08-01
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=198
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer reports that it has detected that the component of the retaining ring does not meet the manufacturing specifications, leading to potentially adverse events occurring on the patient.

Device

Intrathecal catheter Ascenda
  • Modèle / numéro de série
    878,187,808,784
  • Description du dispositif
    It is indicated for use when the patient's therapy requires cornica medication infusion. The system is approved for use with: sterile solution of demorphine hydrochloride / morphine sulfate free of preservatives in the treatment of intractable chronic pain. Intrathecal injection debaclofen in the management of severe spasticity. Sterile solution of ziconotide free of condoms for severe chronic pain management. chronic intravascular infusion defloxuridine and methotrexate for the treatment of primary or metastatic cancer (not for use with the intrathecal catheter ascends)
  • Manufacturer
    Medtronic Neuromodulatiòn

Manufacturer

Medtronic Neuromodulatiòn
  • 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
    NIDFSINVIMA