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 (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 (586Kb). All other patient management recommendations in the March 2009 FSN remain unchanged.
Action
Identify patients where:
-
the pace-sense conductor has fractured,
-
a new pace-sense lead has been inserted and
-
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 (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
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