Events

Alerte De Sécurité sur CONTAK RENEWAL 3 & 4 families of CRT-Ds, VITALITY and VITALITY 2 families of ICDs

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 Hong Kong Limited.

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
    2007-04-13
  • 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/press_20070413.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
    Press release
  • Cause
    Advisory notice on use of heartbeat regulating products the department of health (dh) received notification from a medical device manufacturing company about possible battery life-related problem of certain devices used for regulating heartbeats, including implantable cardiac defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds). the notification from boston scientific hong kong limited involved the following products – a subset of contak renewal 3 & 4 families of crt-ds and a subset of the vitality and vitality 2 families of icds. it was found that the problem is due to a low-voltage capacitor which may be subject to degradation, causing accelerated depletion of the batteries in the affected products. so far 19 of approximately 73,000 devices overseas have been confirmed to have accelerated battery depletion. according to the company, there have not been any reported deaths or serious injuries resulting from the problem, both overseas and locally. according to the boston scientific hong kong limited, in hong kong , 15 devices have been implanted in hospitals under hospital authority (ha) and three in private hospitals. boston scientific has contacted ha and related doctors to advise them to follow up with patients in their clinics as soon as possible. individual patients implanted with affected devices should contact their attending doctors immediately if they have symptoms. patients may call boston scientific hong kong limited's hotline at 2960 7128 or visit boston scientific's website at http://www.Guidant.Com/ppr/advis/2007_04_05.Shtml for further details about the notification. the dh has informed public and private hospitals, and medical professional associations about this notification and advised them to take necessary follow up actions. ends friday, april 13, 2007.

Device

CONTAK RENEWAL 3 & 4 families of CRT-Ds, VITALITY and VITALITY 2 families of ICDs
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Advisory Notice on Use of Heartbeat Regulating Products
  • Manufacturer
    Boston Scientific Hong Kong Limited

Manufacturer

Boston Scientific Hong Kong Limited
  • 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