Events

Safety Alert Or Field Safety Notices for Pacemaker

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Sorin CRM.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2011/056
  • Date
    2011-05-25
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-pacemaker-reply-and-esprit-models-interrogated-with-programmer-containing-software-version-2-24-software-anomaly
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    (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

Pacemaker
  • Model / Serial
  • Product Description
    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
    Sorin CRM

Manufacturer

Sorin CRM
  • Manufacturer Address
    Ms Chantal Cadiou Sorin Group France Tel: +33 146013687 Fax: +33 149655451Email: Chantal.cadiou@sorin.com
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    MHRA