Alerte Ou Avis De Sécurité sur Pacemaker

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/2011/056
  • Date
    2011-05-25
  • 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
    The manufacturer has issued a Field Safety Notice (see appendix) following a programmer software anomaly that could lead to:cardiac instability during surgery when a magnet is applied; or
    unnecessary explant due to inconsistent battery information.This software anomaly sets the magnet rate at 30 beats per minute following interrogation by a programmer with the 2.24 software version.
  • Cause
    (sorin crm) field safety notice published after a programmer software anomaly was found that could lead to cardiac instability or unnecessary explant due to inconsistent battery information. (mda/2011/056).
  • Action
    Do not use a programmer with 2.24 software version. Ensure that the manufacturer has provided you with an alternative software version, 2.26 or higher (or 2.22 if necessary). Identify all patients implanted with Reply or Esprit pacemakers that have previously been interrogated with the 2.24 programmer software version: arrange for follow-up of affected patients in order to interrogate with the alternative software version to correct the magnet rate within 3 months consider the need to review end-of-life explant decisions made following interrogation with 2.24 version.For patients undergoing surgery:Identify affected patients preoperatively interrogate with the alternative software alternatively do not use a magnet in affected patients. If a magnet is used and the heart rate drops to 30 beats per minute, remove the magnet.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Pacemaker.Reply and Esprit models that have been interrogated with programmer containing software version 2.24.Manufactured by Sorin CRM.Model   Serial number configuration (where x is any alphanumeric character)         Reply DR   8xxZKxxx   9xxZKxxx   0xxZKxxx Reply D   8xxZLxxx   9xxZLxxx   0xxZLxxx Reply VDR   8xxZMxxx   9xxZMxxx   0xxZMxxx Reply SR   8xxZNxxx   9xxZNxxx   0xxZNxxx Esprit DR   8xxZPxxx   9xxZPxxx   0xxZPxxx Esprit D   8xxZRxxx   9xxZRxxx   0xxZRxxx Esprit SR   8xxZSxxx   9xxZSxxx   0xxZSxxx Esprit S   8xxZTxxx   9xxZTxxx   0xxZTxxx
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Ms Chantal Cadiou Sorin Group France Tel: +33 146013687 Fax: +33 149655451Email: Chantal.cadiou@sorin.com
  • Société-mère du fabricant (2017)
  • Source
    MHRA