Isoline implantable cardioverter defibrillator (ICD) leads - risk of inappropriate shocking, pacing inhibition or shocking inhibition
(Hospira) Due to insulation abrasion. (MDA/2013/007)
CAS deadlines
Action underway: 7 March 2013, action complete: 21 March 2013
Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up and testing.
Device
Isoline implantable cardioverter defibrillator (ICD) leads.
All models: 2CR5, 2CR6 and 2CT6.
Manufactured by Sorin Group Italia Srl.
Problem
Risk of inappropriate shocking, pacing inhibition or shocking inhibition due to internal insulation abrasion.
Sorin has identified abrasion of internal silicone insulation in 30 returned Isoline leads. This equates to 0.2% of worldwide sales since product launch in 2005. However, the proportion is expected to rise, partly as a result of closer patient follow-up subsequent to this field action. Only one of these incidents occurred in the UK out of approximately 380 leads distributed and none of the incidents was fatal. These incidents typically presented as inappropriate shocks and low pacing impedance, as well as ventricular oversensing where pacing was inhibited. Affected leads were implanted for between 2 months and 4.5 years prior to failure.
Analysis of returned leads revealed insulation abrasion, where the microcables contained within the defibrillator coil were not directly covered with ETFE polymer coating. This abrasion occurred predominantly under the right ventricular electrode, but also under the superior vena cava electrode, when torsion or compression of the lead had occurred. For electrical malfunction to occur, the microcable must abrade towards, and make contact with, the pacing-sensing conductor. Microcable abrasions occur within the defibrillator coil and cannot be detected by X-ray imaging.
Sorin has suspended distribution of all models of the Isoline lead and is recalling all un-implanted stock. The company communicated this to all its customers in an ‘ (67Kb)’ issued on 28 January 2013.
Action
- Do not implant any Isoline ICD leads.
- Identify and return to Sorin any of these leads which have not been implanted.
- Identify all patients implanted with affected models and arrange a follow-up as soon as practicable (within three months).
- Ensure programming parameters are set to maximise the chance of detecting lead issues and avoiding inappropriate therapy, in accordance with advice in the manufacturer’s (67Kb).
- 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.
- Follow up patients at three-monthly intervals.
- At pulse generator replacement, if a decision is made to continue to use the lead, ensure that the replacement generator has remote/advanced monitoring capabilities.
- If there is evidence of a problem with a lead, the risks and benefits of lead replacement 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.
Action by
All cardiologists and cardiac physiologists who manage patients implanted with these 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
Sorin Group Italia Srl
David Thierman
Via Crescentino s.n.
Saluggia, 13040
Tel: +39 0161 487 077
Fax: +39 0161 487 884
Email: david.thierman@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/2013/007 or 2013/001/029/081/032
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
Wales
Enquiries in Wales should be addressed to:
Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk
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