Some EnRhythm® and EnRhythm MRI™ implantable pacemakers - software update may trigger unexpected ERI

(Medtronic) a software update of the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI. (MDA/2011/097)

Device

Implantable pacemakers manufactured by Medtronic.

EnRhythm®: Model P1501DR is a dual chamber rate responsive pacemaker.

EnRhythm MRI™ SureScan: Model EMDR01 IPG is a modified EnRhythm® P1501DR which is MR Conditional.

Problem

Following a software update the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI in some EnRhythm® and EnRhythm MRI™ devices.

The manufacturer issued a Field Safety Notice (34Kb) (FSN) in August 2011 with patient management recommendations updated from a previously issued FSN (in February 2010), which informed healthcare professionals about a software update.

The software update adds a battery impedance ERI threshold that may trigger an unexpected ERI in some devices. Medtronic’s modelling from collected data estimates that approximately 6–10% of devices may reach ERI within five years of implantation. When ERI is triggered, the device reverts to VVI back-up pacing mode (65 beats per minute) which may not be adequate treatment and may cause symptoms associated with pacemaker syndrome for some patients.

These pacemakers are no longer sold in the UK and all devices supplied in the UK reached their use by date by 14 August 2011.

Action

  • Schedule all patients who have received the software update for a follow-up visit to identify devices that triggered ERI shortly after the software update.
  • Patients who have not yet received the software update should be reviewed, and then again within 90 days after the software update to identify if ERI is triggered. 
  • Continue to follow up until device is ready for replacement:
    • every three months if patient is pacemaker dependent, and
    • every six months (or at individual physician’s discretion) if patient is not pacemaker dependent.
  • Schedule device replacement when ERI is triggered.

Action by:

All cardiologists and cardiac physiologists who manage patients implanted with pacemakers.

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)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • General practitioners (for information)
  • 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:

  • Cardiac laboratory technicians
  • Cardiac pacing technicians
  • Cardiac physiologists
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Clinical governance leads
  • Medical directors
  • Nursing executive directors
  • Risk managers

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:
General practitioners (for information)

Independent distribution

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

  • Private medical practitioners

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

Dr David Dunham / Mrs Lezlie Bridge
Medtronic Limited
Building 9
Croxley Green Business Centre
Hatters Lane
Watford WD18 8WW

Tel: 01923 212 213 / 07740 899 216
Fax: 01923 241 004 / 01923 225 273

Email: david.dunham@medtronic.com or lezlie.j.bridge@medtronic.com

Feedback

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

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/097 or 2010/002/010/081/003

Technical aspects

Miss Feza Haque and Mr Simon Holmes
Medicines and Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7066 / 7240
Fax: 020 8754 3965

Email: feza.haque@mhra.gsi.gov.uk or simon.holmes@mhra.gsi.gov.uk

Clinical aspects

Dr Nicola Lennard
Medicines and 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

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

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

http://www.hfs.scot.nhs.uk/online-services/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: Implantable pacemakers manufactured by Medtronic (MDA/2011/097) (391Kb)

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