Pacemaker - Reply and Esprit models interrogated with programmer containing software version 2.24 - software anomaly

(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)

Device

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

Problem

The manufacturer has issued a Field Safety Notice (see appendix) following a programmer software anomaly that could lead to:

  1. cardiac instability during surgery when a magnet is applied; or

  2. 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.

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.

Distribution

This MDA has been sent to:

  • NHS trusts in England (Chief Executives)
  • Care Quality Commission (CQC) (Headquarters) for information
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Equipment Co-ordinators)
  • NHS boards and trusts in Wales (Chief Executives)
  • Primary care trusts in England (Chief Executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E departments
  • Anaesthetists
  • Arrhythmia nurses
  • Cardiac laboratory technicians
  • Cardiac pacing technicians
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Clinical governance leads
  • Coronary care departments
  • Coronary care nurses
  • Directors of nursing
  • Medical directors
  • Operating department practitioners
  • Preoperative assessment units
  • Risk managers
  • Theatre managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Independent treatment centres

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Manufacturer contact

Ms Chantal Cadiou
Sorin Group
France

Tel: +33 146013687
Fax: +33 149655451

Email: Chantal.cadiou@sorin.com

Feedback

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk 

Appendix

Sorin Field Safety Notice and Notification form (35Kb)

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/0556 or 2011/005/003/291/005.

Technical aspects

Michelle Kelly or Simon Holmes
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7145 / 7240
Fax: 020 8754 3965

Email: michelle.kelly@mhra.gsi.gov.uk or simon.holmes@mhra.gsi.gov.uk

Clinical aspects

Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965

Email: nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices.

Further information about CAS can be found on the CAS website

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website .

Further information about SABS can be found on the SABS website .

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) 

Wales

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: Pacemaker. Reply and Esprit models that have been interrogated with programmer containing software version 2.24. Manufactured by Sorin CRM (MDA/2011/056) (710Kb)

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