Events

Alerte De Sécurité sur Paradym DR 8550, CRT 8750 and CRT sonR 8770

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

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
    2010-06-09
  • 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_20100615.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
    Software defect may cause malfunction in implantable cardioverter-defibrillator the department of health (dh) today (june 9) received notification from a local supplier, innotronik hong kong limited (innotronik), about a software problem in three models of implantable cardioverter-defibrillators (icds) manufactured by sorin in italy. the affected 3 models are paradym dr 8550, crt 8750 and crt sonr 8770. the problem is due to a rare software anomaly when dual-chamber backup pacing (i.E.Pacing to both heart atrium and ventricle) is applied. according to the supplier, approximately 2,800 units have been implanted worldwide. as of 7 june this year, sorin has received one confirmed report of defect. no patient injury or death has occurred as a result of the identified software anomaly. according to innotronik, a software update will eliminate this risk. the new software will be updated to the patient's icd in the next scheduled check-up. innotronik informed that three paradym dr 8550 icds have been implanted as single chamber backup pacing in hong kong. the risk of these patients being affected by this software anomaly is low. innotronik has set up a hotline (tel no. 2877 6787) for enquiries. a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell. meanwhile, the dh will inform public and private hospitals, medical associations and healthcare professionals and will also follow up with innotronik on further developments, if any. ends/wednesday, june 9, 2010.

Device

Paradym DR 8550, CRT 8750 and CRT sonR 8770
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Software defect may cause malfunction in implantable cardioverter-defibrillator
  • Manufacturer
    Sorin in Italy

Manufacturer

Sorin in Italy