SQ-RX® pulse generator, model 1010 - subcutaneous implantable cardioverter defibrillator (S-ICD) - battery might die early

(Cameron Health) risk of premature depletion of battery before the 3 nominal months. (MDA/2011/067)

Device

Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010.

Manufactured by Cameron Health.

Problem

Risk of S-ICD being unable to deliver shock for therapy after elective replacement indicator (ERI) audible warning.

The ERI may occur earlier than expected and the end of life (EOL) indicator may occur before the nominal 3 months.

The manufacturer has identified two populations of devices in the UK that are at higher risk of premature battery depletion.

Population 1: 33% risk of premature battery failure over five years – three devices in the UK.

Population 2: 3.3% risk of premature battery failure over five years – 81 devices in the UK.

The MHRA has received one confirmed report of premature battery failure associated with this issue, occurring after 9 months.

Bench tests performed by the manufacturer showed that the affected devices may deplete over a period of between one month and 2 years.

Cameron Health issued a Field Safety Notice on 1 June 2011 (130Kb) to highlight this risk to physicians.

Please note that the FSN contains worldwide number of affected devices.

Action

  • Identify all patients with affected S-ICD (see appendix) and schedule immediate follow-up to:
    • familiarise patients with audible alert on the S-ICD (using magnet)
    • remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of symptoms or the onset of any audible patient alarm.
  • For patients identified in population 1, consider an immediate box change only for high risk patients, such that they are likely to require multiple shocks within the space of a few days.
  • For all patients in population 2, arrange follow-up at three-month intervals, to review if the battery voltage is dropping at a faster rate than predicted.

Distribution

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • Local authorities in Scotland (equipment coordinators)
  • 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 managers
  • 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:

  • Hospitals in the independent sector

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

Stephen O’Connor
Cameron Health
4 The Green
Bromham
Bedfordshire
MK43 8JR

Tel: 07984 590 639
Fax: 01223 280 382

Email: soconnor@cameronhealth.com

Feedback

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk  

Appendix

Cameron Health Field Safety Notice (415Kb)

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/067 or 2011/004/011/081/017.

Technical aspects

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

Tel: 020 3080 6243 or 7242
Fax: 020 8754 3965

Email: nicola.harris@mhra.gsi.gov.uk or sam.baxter@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: Subcutaneous implantable cardioverter defibrillator (S-ICD): SQ-RX® pulse generator, model 1010. Manufactured by Cameron Health (MDA/2011/067) (586Kb)

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