Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - risk of inappropriate shocks

(Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (MDA/2011/051)

Device

Implantable cardioverter defibrillator (ICD) lead.

Sprint Fidelis, model numbers: 6930, 6931, 6948 and 6949.

Manufactured by Medtronic.

Problem

Risk of inappropriate shocks and loss of therapy.

Increased risk that the high voltage conductor will fracture if the pace-sense conductor has previously fractured in the same lead.

In March 2009 Medtronic issued a Field Safety Notice (FSN) (42Kb) advising clinicians that one option for dealing with this problem was to implant a new pace-sense lead while maintaining the use of the high voltage conductor.

However, Medtronic estimates that the survival for the Sprint Fidelis high voltage conductor is 77.7% at 21 months if a pace-sense conductor fracture has previously occurred. Therefore, Medtronic no longer recommends this course of action and has issued another FSN (April 2011) (586Kb). All other patient management recommendations in the March 2009 FSN remain unchanged.

Action

Identify patients where:

  1. the pace-sense conductor has fractured,

  2. a new pace-sense lead has been inserted and

  3. the high voltage conductor remains in use.

For these patients, consider the need to implant a new high voltage conductor at elective device change, taking into account the age and clinical circumstances of the patient.

If these patients are at high risk of sudden cardiac death in the event of high voltage conductor failure, then consider elective lead replacement before device change.

Where a new conductor fracture occurs, implant a new high voltage lead. Where a lead is functioning normally, continue with existing patient management recommendations and use of Medtronic Lead Integrity Alert (LIA). This should be done taking into account the recent update in long term lead survival data presented in the FSN (April 2011) (586Kb).

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
  • 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
  • Medical directors
  • Risk 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

Mrs Lezlie Bridge
Medtronic Limited
Building 9
Croxley Green Business Park
Hatters Lane
Watford
Hertfordshire
WD18 8WW

Tel: 01923 212 213
Fax: 01923 225 273

Email: 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/2011/051 or 2011/004/004/291/016.

Technical aspects

Ms Sam Baxter or Mr Guido Fumagalli
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7242 / 7144
Fax: 020 8754 3965

Email: sam.baxter@mhra.gsi.gov.uk and guido.fumagalli@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: Sprint Fidelis implantable cardioverter defibrillator (ICD) lead, various model numbers manufactured by Medtronic (MDA/2011/051) (355Kb)

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