Implantable cardioverter defibrillator (ICD) - risks with pacing inhibition

(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)

Device

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.

Problem

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.

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.

Action by

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

Distribution

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (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 physiologists
  • Cardiologists
  • Medical directors

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: 0033 146013687
Fax: 0033 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 

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/073 or 2011/005/003/291/018.

Technical aspects

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

Tel: 020 3080 7145 / 7242
Fax: 020 8754 3965

Email: michelle.kelly@mhra.gsi.gov.uk or sam.baxter@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: Implantable cardioverter defibrillator (ICD) manufactured by Sorin CRM. MDA/2011/073 (235Kb)

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