Events

Avis De Sécurité sur INGEVITY™ MRI uitdraaibare/terugdraaibare stimulatie-elektrode

Selon Inspectie Gezondheidszorg en Jeugd, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Netherlands qui a été fabriqué par Boston Scientific.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2018-04-26
  • Pays de l'événement
    Netherlands
  • Source de l'événement
    IGJ
  • URL de la source de l'événement
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/04/26/boston-scientific-fsca92160868---ingevity%E2%84%A2-mri-uitdraaibare-terugdraaibare-stimulatie-elektrode
  • Notes / Alertes
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notes supplémentaires dans les données
  • Cause
    In september 2017, we sent updates to the electrode physician's manual (plm) for the ingevity ™ mri swivel / revolving stimulation electrode (with active fixation) to implant centers in france as safety bulletin. following subsequent discussions, other competent european authorities have asked us to send the same plm update to all centers in europe as safety bulletin.

Device

INGEVITY™ MRI uitdraaibare/terugdraaibare stimulatie-elektrode

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.” Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ