Four Bipolar QuickSite and QuickFlex lead models – risk of worsening heart failure symptoms due to wear and/or abrasion of lead insulation after implantation
- Medicines and Healthcare products Regulatory Agency
- 21 June 2016
- 21 June 2012
- Alert type:
- Medical device alert
Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.
- Return patient follow-up to the standard practice of reviewing lead performance at 6-monthly intervals, following your own standard procedures.
- Prophylactic replacement of these devices is not recommended except in exceptional circumstances.
- Ensure all patients are enrolled on remote monitoring where possible, in discussion with St Jude Medical.
All cardiologists and cardiac physiologists who manage patients implanted with CRT leads.
Deadlines for actions
Actions underway: 5 July 2016
Actions complete: 21 July 2016
Update on MHRA advice
MHRA issued Medical Device Alert MDA/2012/021 in April 2012 advising UK hospitals not to implant QuickSite and QuickFlex leads, and to follow up every 3 months all patients already implanted with these leads.
The risk to patients involves worsening heart failure symptoms due to wear and/or abrasion of the lead’s softer, outer silicone insulation after implantation (referred to as externalised conductors). However, the likelihood of an electrical anomaly or adverse clinical event is low, as the lead will continue to function normally as long as the harder, inner insulation remains intact.
Approximately 6,000 QuickSite and QuickFlex leads were implanted in the UK since they were first sold in 2004. They were discontinued, and unused product recalled in 2012. Around 2,600 active leads are estimated to remain implanted in UK patients today.
Although the prevalence of confirmed cases of externalised conductors among these leads was only 0.023% in April 2012, at that time the manufacturer estimated that this problem could in fact be present in as much as 3-4% of the patient population. Four years later, a review of the latest data suggests the overall rate for externalised conductors is currently no more than 0.15%.
Based on the present low occurrence rate and the low risk of a clinical event, the MHRA is now advising UK hospitals to revert back to UK standard practice of 6-monthly follow up for patients implanted with these leads. However, it remains important that as many patients as possible with compatible ICDs benefit from additional home monitoring, and centres are encouraged to consider this option. Currently the manufacturer estimates that just over 10% of UK patients with leads remaining in active use are being followed by remote monitoring.
St Jude Medical UK Ltd
Tel: 01789 207637
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Cardiac laboratory technicians
- Cardiac pacing technicians
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Clinical governance leads
- Coronary care departments
- Coronary care nurses
- EBME departments
- Medical directors
- Medical libraries
- Radiology departments
- Risk managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- General practice managers
- General practice nurses
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
Establishments registered with the Care Quality Commission (CQC) (England only)
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Domiciliary care providers
- Further education colleges registered as care homes
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/007 or 2012/003/029/291/011
Dr S Jagdish, Senior Clinical Advisor, MHRA Tel: 020 3080 7187
Reporting adverse incidents in England Through Yellow Card
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Fax: 028 9052 3900
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 21 June 2016
Issued: 21 June 2012
Alert type: Medical device alert