Alerte Ou Avis De Sécurité sur Implantable cardioverter defibrillator (ICD)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Sorin CRM.

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
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2011/073
  • Date
    2011-06-29
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 United Kingdom.
  • Notes supplémentaires dans les données
    Risk of bradycardia / syncope due to pacing inhibition. Potential for pacing inhibition associated with ventricular oversensing if the follow-up monitoring feature, PhD, is programmed ON and the device is connected to high polarisation defibrillation leads. The manufacturer issued a Field Safety Notice (FSN) on 27 April 2011.
  • Cause
    (sorin crm) pacing inhibition causes risk of bradycardia / syncope; also potential association between pacing inhibition and ventricular oversensing if 'phd' is 'on' and the device is connected to high polarisation defibrillation leads. (mda/2011/073).
  • Action
    Identify patients implanted with a Paradym ICD and for those patients known to be pacemaker dependent arrange follow-up within 1 month, in order to turn OFF the PhD feature. for all other affected patients, arrange for follow-up within 3 months in order to turn OFF the PhD feature. Put systems in place to ensure that the PhD feature is switched off at the end of every programming session until the programmer software upgrade has been implemented Note: The PhD feature is automatically activated when the shock therapy is switched on. Put systems in place to ensure that the PhD feature is switched OFF in newly implanted Paradym ICDs.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Implantable cardioverter defibrillator (ICD) manufactured by Sorin CRM.Paradym, model numbers: VR 8250, DR 8550, CRT-D 8750 and 8770, VR 9250, DR 9550, CRT-D 9750 and 9770.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Ms Chantal Cadiou Sorin Group France Tel: 0033 146013687 Fax: 0033 149655451Email: Chantal.cadiou@sorin.com
  • Société-mère du fabricant (2017)
  • Source
    MHRA