Events

Alerte De Sécurité sur Temporary endocardial stimulation cable 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 France S.

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
    R1606-252
  • Numéro de l'événement
    2005V-0003497
  • Date
    2016-06-15
  • 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=136
  • 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 referenced device does not meet the requirements of section 8.5.2.3 of the international standard iec 60601-1 and the corresponding provision 21 crf 898 of the fda in relation to the design standards to prevent the connection of the patient's cable to possibly dangerous voltages, this situation could be possible if the instructions for use are not followed properly, leading to the potential occurrence of adverse events on patients.

Device

Temporary endocardial stimulation cable system
  • Modèle / numéro de série
    6416, all batches manufactured after May 1, 2014
  • Description du dispositif
    The MEDTRONIC model 6416 temporary transvenous stimulation cable system has a bipolar active fixation cable and a lubri- cated lubricant guide catheter. This system has been designed for temporary intracardiac stimulation and the recording of electrocardiograms. It is a disposable system, for temporary use with only one patient, with an estimated implant duration of 7 days or less.
  • Manufacturer
    Medtronic France S

Manufacturer

Medtronic France S
  • 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