Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Boston Scientific Cardiac Rhythm Management Group.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 094 09 18 000
  • Date de mise en oeuvre de l'événement
    2018-09-20
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13203
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    The pacemaker manual describes how increases in pacing requirements or changes in programmed parameters may result in an expected longevity reduction and are considered normal battery depletion. however, hydrogen exposure within the pacemaker’s circuitry may compromise the electrical performance of low voltage capacitors causing current leakage and a moderate acceleration in the rate of battery depletion. because this accelerated depletion does not occur rapidly, a follow-up interval of no more than six months is recommended. boston scientific has determined a liner component to be the source of hydrogen and identified a subset of previously distributed pacemakers that have an elevated potential for exhibiting this behavior. boston scientific pacemakers include automated diagnostic tools, including battery status assessment and estimated longevity predictions, that dynamically adjust based on power consumption. it is important to emphasize that the accuracy of battery status and longevity estimates are not affected by this behavior.

Device

Cardiac Resynchronization Therapy pacemakers (VISIONIST™, ™,) and pacemakers (ACCOLADE™, PROPONE...
  • Modèle / numéro de série
    ACCOLADE™ & ACCOLADE™ MRI : L300, L301, L321 & L310, L311, L331 L200, L221 & L210, L211, L231 ESSENTIO™ & ESSENTIO™ MRI : L100, L101, L121 & L110, L111, L131 VISIONIST™ X4 : U228 VALITUDE™ X : 4 U128
  • Description du dispositif
    pacemakers
  • Manufacturer
    Boston Scientific Cardiac Rhythm Management Group

Manufacturer

Boston Scientific Cardiac Rhythm Management Group
  • 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.”
  • Représentant du fabricant
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA