Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads Manufactured by St Jude Medical (MDA/2012/061)

This Medical Device Alert has been issued as there is a risk of inappropriate shock or therapy failure due to wear of lead insulation when using implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical. These patient follow-up recommendations replace those given previously in MDA/2010/095 and MDA/2011/112.

CAS deadlines

Action underway: 24 September 2012, action complete: 8 October 2012

Device

Implantable cardioverter defibrillator (ICD) leads.

Riata and Riata ST – all silicone coated models.

Manufactured by St Jude Medical.

Problem

Risk of inappropriate shock or therapy failure due to wear of lead insulation after implantation.

These patient follow-up recommendations replace those given previously in MDA/2010/095 and MDA/2011/112.

In December 2011, the MHRA issued a Medical Device Alert (MDA/2011/112) recommending enhanced patient follow-up for all patients implanted with Riata and Riata ST lead models. At that time the frequency of follow-up was stratified according to lead model. Current evidence suggests that the difference in prevalence of externalised cables between 8Fr and 7Fr lead models is decreasing.

St Jude Medical has recently issued a Field Safety Notice (155Kb) (dated 13 July 2012) detailing phase I of a Riata lead evaluation study to investigate the prevalence of externalised cables using fluoroscopy. The clinical significance of externalised cables will not, however, be evident until phase II of the study is completed; this is unlikely to be before the end of 2013. For this reason this Medical Device Alert is focusing on detection of early signs of functional lead failure, as these lead models continue to fail at a higher rate.

Action

  • Continue to follow up all patients implanted with Riata or Riata ST ICD lead models to identify any changes in lead performance, according to your own standard procedures (see further advice below). Undertake this:
    • at three-month intervals (in clinic or via remote monitoring) to -
      • monitor for HV lead noise using an unused EGM channel
      • turn on RV AutoCapture™ (or equivalent) pacing to monitor pacing thresholds 
    • and at six-month intervals (in clinic) to -
      • ensure high voltage lead integrity (HVLI)  testing is performed.
  • At box change, if a decision is made to continue to use the lead, ensure that the replacement device has remote/advanced monitoring capabilities.
  • Consider the need for further examination e.g. by ECG or fluoroscopy*, if a lead failure is suspected.
  • If a lead failure is confirmed, the risks and benefits of lead replacement options should be evaluated on a case-by-case basis in discussion with the patient.

Note: Prophylactic lead explantation is not recommended, other than in exceptional clinical circumstances.

  • In all cases, the benefit of fluoroscopic screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000.

Further advice

  • Where appropriate for patients, follow-up should continue to include:
    • provocative testing (e.g. shoulder/arm movements and deep respiration), which may help reveal an   intermittent problem
    • increasing the detection time of the VT zone to reduce the risk of oversensing and inappropriate
      shocks
    • ensuring the SVT discriminators are on, where applicable
    • ensuring that the lead impedance alarms are programmed on.
  • Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any patient alert.
  • Report all lead adverse incidents to the MHRA and to St Jude Medical.

Action by

All cardiologists and cardiac physiologists who manage patients implanted with ICD leads.

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 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 laboratory technicians
  • Cardiac pacing technicians
  • Cardiac physiologists
  • Cardiologists
  • Cardiothoracic surgeons
  • Clinical governance leads
  • Medical directors
  • Nursing executive directors

Independent distribution

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

  • Hospitals in the independent sector
  • 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

St Jude Medical UK Ltd
Sean Hogarth
Capulet House
Stratford Business and Technology Park 
Stratford Upon Avon 
CV37 7GX 

Tel: 01789 207 600 
Fax: 01789 207 601

Email:  shogarth@sjm.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/2012/061 or 2012/007/020/081/010

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 or 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)Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
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) leads Manufactured by St Jude Medical (MDA/2012/061) (56Kb)

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