Events

Alerte De Sécurité sur COGNIS®, TELIGEN®, INCEPTA™, PUNCTUA™, and ENERGEN™ CRT-Ds and ICDs, and LATITUDE® remote patient monitoring system

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Boston Scientific.

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
  • Date
    2011-10-28
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111028.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: boston scientific cognis®, teligen®, incepta™, punctua™, and energen™ crt-ds and icds, and latitude® remote patient monitoring system medical device manufacturer, boston scientific, has issued a letter to physician to explain changes in lead configuration preferences and new test methodology in cognis®, teligen®, incepta™, punctua™, and energen™ defibrillator families, and clarifies how to interpret test result differences from prior defibrillator-lead combinations. current boston scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and latitude monitoring system via the daily measurements feature. a measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a “red alert” within latitude (if activated). however, the measured value that prompted the alert is not displayed. similarly, out-of-range impedance measurements are not plotted on programmer or latitude trending graphs. boston scientific has received reports that, in some instances, this has made it more difficult for physicians to troubleshoot the system and determine whether the out-of-range impedance value truly reflected an underlying lead/system issue. if you are in possession of the affected products, please contact boston scientific technical services for instructions on how to obtain more detailed shock lead impedance information when needed.

Device

COGNIS®, TELIGEN®, INCEPTA™, PUNCTUA™, and ENERGEN™ CRT-Ds and ICDs, and LATITUDE® remote patient...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific COGNISR, TELIGENR, INCEPTATM, PUNCTUATM, and ENERGENTM CRT-Ds and ICDs, and LATITUDER remote patient monitoring system
  • Manufacturer
    Boston Scientific

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.”
  • Source
    DH