Events

Alerte De Sécurité sur neurostimulation system

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 Inc. Cardiac Rhythm Disease || Medtronic Neuromodulation || Medtronic Bv || Medtronic Puerto Rico Operations Co., Villalba.

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
    I1611-499
  • Numéro de l'événement
    2008DM-0002561 ; 2014DM-0011010
  • Date
    2016-10-28
  • 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=116
  • 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 a problem in the referenced shippers, which could stop responding and emit beeps, additionally provide the necessary recommendations on how to prevent this problem from occurring and how to restore the functionality of the shipper in case it occurs, this failure could lead to the occurrence potential adverse events on the patients.

Device

neurostimulation system
  • Modèle / numéro de série
    model 37751 chargers, used with the following references: Restore, RestoreUltra (Model || 37712), RestoreAdvanced (Model 37713), RestoreSensor || (Model 37714), RestoreUltra SureScan MRI (Model || 97712), RestoreAdvanved SureScan MRI (Model 97713), || RestoreSensor SureScan MRI (Model 97714), serial || specific.
  • Description du dispositif
    It is used to evaluate neurostimulation systems. For chronic and untreatable pain of the trunk and / or limbs including unilateral and bilateral pain.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease || Medtronic Neuromodulation || Medtronic Bv || Medtronic Puerto Rico Operations Co., Villalba

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease || Medtronic Neuromodulation || Medtronic Bv || Medtronic P...
  • 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